Post Operative Pain
Conditions
Keywords
surgical pain, acute pain, Acute Post Surgical Pain
Brief summary
The purpose of this study is to evaluate the effectiveness, tolerability, and safety of oxymorphone immediate release (IR) oral liquid as an analgesic for acute postoperative pain in pediatric subjects. This post marketing study was required by the FDA. Endo Pharmaceuticals Inc. no longer promotes opioids and no longer markets Opana® ER.
Interventions
DRUGoxymorphone HCl
Comparison of different dosages of drug, 0.05mg/kg, 0.10mg/kg, 0.15mg/kg or 0.20mg/kg oral liquid oxymorphone
Sponsors
Endo Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
1. Males or females between 2 to ≤12 years of age. Females of child-bearing potential must be practicing abstinence or using a medically acceptable form of contraception (eg, intrauterine device, hormonal birth control, or double barrier method). For the purpose of this study, all peri- and post-pubertal females will be considered to be of child-bearing potential unless they are biologically sterile or surgically sterile for more than 1 year 2. Subjects must be at least 10 kg and BMI ≤30 3. Scheduled to have a surgery for which oral opioid analgesia will be needed to manage postoperative pain for at least 24 hours (Single-Dose Phase) or 48 hours (Multiple-Dose Phase)following intraoperative and/or postoperative parenteral analgesia 4. Be hospital inpatients, expected to be hospitalized for at least 24 hours (Single-Dose Phase) and 48 hours (Multiple-Dose Phase) following the initial administration of oxymorphone immediate release 5. Available lab results, either intraoperatively (prior to surgical incision) or from within 21 days preoperatively, for clinical chemistry and hematology laboratory analytes (the results must have been reviewed by the Investigator for study eligibility) 6. Able to provide pain assessment evaluations using an age-appropriate instrument provided in the protocol 7. On an intravenous analgesic regimen utilizing a short-acting opioid analgesic following surgery AND anticipated to be switched to an oral opioid as part of the analgesic regimen (according to institution SOC) 8. Demonstrated the ability to tolerate clear fluids following surgery according to the SOC at each institution 9. Informed of the nature of the study and written informed consent has been obtained from the legally responsible parent(s)/legal guardian(s) 10. Provided assent in accordance with IRB requirements 11. Line in place for blood sampling
Exclusion criteria
1. Known allergies or sensitivities to oxymorphone or other opioid analgesics 2. Known sensitivity to any component of the study drug 3. Life expectancy \<4 weeks 4. Positive pregnancy test at screening (females of reproductive age only) 5. Pregnant and/or lactating 6. Cyanotic heart disease 7. Respiratory, hepatic, renal, neurological, psychological disease, or any other clinically significant condition that would, in the Investigator's opinion, preclude participation in the study 8. Preoperative opioids administered for a period of more than 72 hours in duration 9. Abdominal trauma that would interfere with absorption of study drug 10. Increased intracranial pressure 11. Respiratory condition requiring intubation 12. History of uncontrolled seizures that are not being managed with anticonvulsants 13. Significant prior history of substance abuse or alcohol abuse 14. Received any investigational drug within 30 days prior to the first dose of study drug, or are scheduled to receive an investigational drug other than oxymorphone HCl immediate-release oral liquid during the course of the study 15. Received a monoamine oxidase inhibitor (MAOI) within 14 days prior to the start of study drug 16. Received oxycodone or oxymorphone within 48 hours prior to study start 17. Investigator anticipates that the subject and/or parent(s)/legal guardian(s) would be unable to comply with the protocol 18. Subject (and/or parent\[s\]/legal guardian\[s\]) is(are) unable to communicate effectively with study personnel at an age-appropriate level
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase | Baseline, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose; and at the time of rescue | Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group, (0 = no pain and 10 = very much pain). Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 years and 0 years to \< 2 years age groups, (0 = no pain and 10 = very much pain). |
| Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase | Baseline (prior to dose); 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose; and at the time of rescue | Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group, (0 = no pain and 10 = very much pain). Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 years and 0 years to \< 2 years age groups, (0 = no pain and 10 = very much pain). PID was calculated as the pain intensity score at baseline minus the current pain intensity score at each corresponding time point. |
| Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase | Baseline, 0.5, 1, 1.5, 2, hours post dose, and immediately prior to all remaining doses administered through 48 hours after administration of the initial dose; and at time of rescue | Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group, (0 = no pain and 10 = very much pain). Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 years and 0 years to \< 2 years age groups, (0 = no pain and 10 = very much pain) |
| Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase | 0.5, 1, 1.5, 2, hours post dose 1 through to Dose 12, 0 Hour; End of Study/Early Termination | Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group, (0 = no pain and 10 = very much pain). Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 years and 0 years to \< 2 years age groups, (0 = no pain and 10 = very much pain). PID is calculated as the pain intensity score at baseline minus the current pain intensity score at each corresponding time point. |
| Number (%) of Subjects With Rescue Medication Use by Age and Dose Group in Multiple-Dose Phase | Rescue Medication Use | Rescue Medication Use in Multiple Dose Phase |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxymorphone AUC0-inf Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose | AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn |
| Oxymorphone AUC0-24 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose | AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule |
| Oxymorphone t1/2 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose | t1/2: Terminal half-life, calculated as λn/(ln 2) |
| Dose-Normalized Oxymorphone CL/F Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose | CL/F: Apparent oral clearance, calculated as Dose/AUC0-inf |
| Dose-Normalized Oxymorphone V/F Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose | V/F: Apparent volume of distribution, calculated as Dose/(AUC0-inf \* λn) |
| Oxymorphone Cmax Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7 | Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval |
| Oxymorphone Tmax Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7 | Tmax: The time at which Cmax was observed |
| Oxymorphone Clast Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7 | Clast: Minimum plasma concentration; the last concentration observed during a dosage interval |
| Oxymorphone Tlast Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7 | Tlast: The time at which Clast was observed |
| Oxymorphone AUC0-t Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7 | AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule |
| Oxymorphone AUC0-inf Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7 | AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn |
| Oxymorphone AUC0-24 Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7 | AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule |
| Oxymorphone t1/2 Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7 | t1/2: Terminal half-life, calculated as λn/(ln 2) |
| 6 Beta-Hydroxyoxymorphone Cmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose | Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval |
| 6 Beta-Hydroxyoxymorphone Tmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose | Tmax: The time at which Cmax was observed |
| 6 Beta-Hydroxyoxymorphone Clast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose | Clast: Minimum plasma concentration; the last concentration observed during a dosage interval |
| 6 Beta-Hydroxyoxymorphone Tlast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose | Tlast: The time at which Clast was observed |
| 6 Beta-Hydroxyoxymorphone AUC0-t Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose | AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule |
| 6 Beta-Hydroxyoxymorphone AUC0-inf Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose | AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn |
| 6 Beta-Hydroxyoxymorphone AUC0-24 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose | AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule |
| 6 Beta-Hydroxyoxymorphone t1/2 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose | t1/2: Terminal half-life, calculated as λn/(ln 2) |
| Dose-Normalized 6 Beta-Hydroxyoxymorphone CL/F Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose | CL/F: Apparent oral clearance, calculated as Dose/AUC0-inf |
| Dose-Normalized 6 Beta-Hydroxyoxymorphone V/F Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose | V/F: Apparent volume of distribution, calculated as Dose/(AUC0-inf \* λn) |
| 6 Beta-Hydroxyoxymorphone Cmax Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7 | Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval |
| 6 Beta-Hydroxyoxymorphone Tmax Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7 | Tmax: The time at which Cmax was observed |
| 6 Beta-Hydroxyoxymorphone Clast Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7 | Clast: Minimum plasma concentration; the last concentration observed during a dosage interval |
| 6 Beta-Hydroxyoxymorphone Tlast Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7 | Tlast: The time at which Clast was observed |
| 6 Beta-Hydroxyoxymorphone AUC0-t Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7 | AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule |
| 6 Beta-Hydroxyoxymorphone AUC0-inf Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7 | AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn |
| 6 Beta-Hydroxyoxymorphone AUC0-24 Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7 | AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule |
| Oxymorphone Cmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose | Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval |
| 6 Beta-Hydroxyoxymorphone t1/2 Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7 | t1/2: Terminal half-life, calculated as λn/(ln 2) |
| Oxymorphone Tmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose | Tmax: The time at which Cmax was observed |
| Oxymorphone Clast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose | Clast: Minimum plasma concentration; the last concentration observed during a dosage interval |
| Oxymorphone Tlast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose | Tlast: The time at which Clast was observed |
| Oxymorphone AUC0-t Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose | AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Dose Phase 6 to ≤12 Years Age Group: 0.05 mg/kg 6 to ≤12 year age group in the Single Dose Phase given 0.05 mg/kg oxymorphone HCl IR oral liquid | 6 |
| Single-Dose Phase 6 to ≤12 Years Age Group: 0.10 mg/kg 6 to ≤12 year age group in the Single Dose Phase given 0.10 mg/kg oxymorphone HCl IR oral liquid | 6 |
| Single Dose Phase 6 to ≤12 Years Age Group: 0.20 mg/kg 6 to ≤12 year age group in the Single Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid | 7 |
| Single Dose Phase 2 to <6 Years Age Group: 0.05 mg/kg 2 to \<6 Years age group in the Single Dose Phase given 0.05 mg/kg oxymorphone HCl IR oral liquid | 7 |
| Single Dose Phase 2 to <6 Years Age Group: 0.10 mg/kg 2 to \<6 Years age group in the Single Dose Phase given 0.10 mg/kg oxymorphone HCl IR oral liquid | 6 |
| Single Dose Phase 2 to <6 Years Age Group: 0.20 mg/kg 2 to \<6 Years age group in the Single Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid | 6 |
| Single Dose Phase 0 to < 2 Years Age Group: 0.05 mg/kg 0 to \< 2 Years age group in the Single Dose Phase given 0.05 mg/kg oxymorphone HCl IR oral liquid | 7 |
| Multiple Dose Phase 6 to ≤12 Years Age Group: 0.20 mg/kg 6 to ≤12 year age group in the Multiple Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid | 10 |
| Multiple Dose Phase 2 to <6 Years Age Group: 0.20 mg/kg 2 to \<6 year age group in the Multiple Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid | 6 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 |
| Overall Study | Lack of Efficacy | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Patient Discharged Early | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Single Dose Phase 6 to ≤12 Years Age Group: 0.05 mg/kg | Total | Multiple Dose Phase 2 to <6 Years Age Group: 0.20 mg/kg | Multiple Dose Phase 6 to ≤12 Years Age Group: 0.20 mg/kg | Single Dose Phase 0 to < 2 Years Age Group: 0.05 mg/kg | Single Dose Phase 2 to <6 Years Age Group: 0.20 mg/kg | Single Dose Phase 2 to <6 Years Age Group: 0.10 mg/kg | Single Dose Phase 2 to <6 Years Age Group: 0.05 mg/kg | Single Dose Phase 6 to ≤12 Years Age Group: 0.20 mg/kg | Single-Dose Phase 6 to ≤12 Years Age Group: 0.10 mg/kg |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 8.3 years STANDARD_DEVIATION 1.75 | 5.8 years STANDARD_DEVIATION 3.56 | 3.8 years STANDARD_DEVIATION 1.17 | 9.6 years STANDARD_DEVIATION 1.9 | 0.4 years STANDARD_DEVIATION 0.53 | 3.5 years STANDARD_DEVIATION 1.38 | 3.5 years STANDARD_DEVIATION 1.38 | 3.4 years STANDARD_DEVIATION 1.27 | 9.0 years STANDARD_DEVIATION 2.16 | 8.7 years STANDARD_DEVIATION 1.86 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 58 Participants | 6 Participants | 10 Participants | 7 Participants | 4 Participants | 6 Participants | 7 Participants | 6 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 12 Participants | 1 Participants | 3 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 45 Participants | 5 Participants | 7 Participants | 6 Participants | 6 Participants | 4 Participants | 4 Participants | 6 Participants | 3 Participants |
| Sex: Female, Male Female | 1 Participants | 26 Participants | 0 Participants | 5 Participants | 1 Participants | 6 Participants | 3 Participants | 2 Participants | 6 Participants | 2 Participants |
| Sex: Female, Male Male | 5 Participants | 35 Participants | 6 Participants | 5 Participants | 6 Participants | 0 Participants | 3 Participants | 5 Participants | 1 Participants | 4 Participants |
| Weight | 35.25 kg STANDARD_DEVIATION 11.725 | 25.84 kg STANDARD_DEVIATION 16.311 | 17.83 kg STANDARD_DEVIATION 2.701 | 41.81 kg STANDARD_DEVIATION 18.103 | 9.10 kg STANDARD_DEVIATION 3.106 | 17.88 kg STANDARD_DEVIATION 4.869 | 15.77 kg STANDARD_DEVIATION 4.303 | 18.76 kg STANDARD_DEVIATION 4.026 | 37.26 kg STANDARD_DEVIATION 20.613 | 30.33 kg STANDARD_DEVIATION 17.731 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 | 0 / 7 | 0 / 7 | 0 / 6 | 0 / 6 | 0 / 7 | 0 / 10 | 0 / 6 |
| other Total, other adverse events | 5 / 6 | 4 / 6 | 4 / 7 | 7 / 7 | 5 / 6 | 3 / 6 | 4 / 7 | 10 / 10 | 4 / 6 |
| serious Total, serious adverse events | 0 / 6 | 1 / 6 | 0 / 7 | 1 / 7 | 0 / 6 | 0 / 6 | 0 / 7 | 2 / 10 | 0 / 6 |
Outcome results
Primary
Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase
Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group, (0 = no pain and 10 = very much pain). Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 years and 0 years to \< 2 years age groups, (0 = no pain and 10 = very much pain). PID is calculated as the pain intensity score at baseline minus the current pain intensity score at each corresponding time point.
Time frame: 0.5, 1, 1.5, 2, hours post dose 1 through to Dose 12, 0 Hour; End of Study/Early Termination
Population: Effectiveness Population.IDMC recommended dose: 0.20 mg/kg oxymorphone HCl oral solution for the Multiple-dose Phase. Therefore, the analyses were conducted in a total of 16 subjects ranging from 2 to ≤12 years who received the dose of 0.20 mg/kg oxymorphone HCl oral solution as shown in the table of baseline characteristic in the participant flow.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase | Dose 6, 0 Hour | 1.0 score on a scale | Standard Deviation 2.58 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase | Dose 1, 1 Hour Post-Dose | 0.9 score on a scale | Standard Deviation 2.67 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase | Dose 7, 0 Hour | 0.5 score on a scale | Standard Deviation 2.52 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase | Dose 8, 0 Hour | -2.0 score on a scale | Standard Deviation 2 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase | Dose 9, 0 Hour | 2.7 score on a scale | Standard Deviation 1.15 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase | Dose 10, 0 Hour | 2.0 score on a scale | Standard Deviation 2 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase | Dose 11, 0 Hour | 3.0 score on a scale | Standard Deviation 1.41 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase | Dose 12, 0 Hour | 0.0 score on a scale | Standard Deviation 5.66 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase | End of Study/Early Termination | -0.5 score on a scale | Standard Deviation 1.91 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase | Dose 1, 30 Minutes Post-Dose | 0.4 score on a scale | Standard Deviation 2.19 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase | Dose 3, 0 Hour | -3.5 score on a scale | Standard Deviation 4.43 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase | Dose 1, 2 Hours Post-Dose | 0.0 score on a scale | Standard Deviation 1.85 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase | Dose 4, 0 Hour | -0.8 score on a scale | Standard Deviation 3.03 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase | Dose 1, 1.5 Hours Post-Dose | 1.1 score on a scale | Standard Deviation 3.02 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase | Dose 5, 0 Hour | 1.0 score on a scale | Standard Deviation 1.15 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase | Dose 2, 0 Hour | -2.3 score on a scale | Standard Deviation 3.88 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase | End of Study/Early Termination | 3.5 score on a scale | Standard Deviation 3.11 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase | Dose 1, 30 Minutes Post-Dose | 2.2 score on a scale | Standard Deviation 2.79 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase | Dose 1, 1 Hour Post-Dose | 2.0 score on a scale | Standard Deviation 3.46 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase | Dose 1, 1.5 Hours Post-Dose | 4.8 score on a scale | Standard Deviation 3.3 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase | Dose 1, 2 Hours Post-Dose | 4.8 score on a scale | Standard Deviation 3.3 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase | Dose 2, 0 Hour | 0.3 score on a scale | Standard Deviation 1.53 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase | Dose 3, 0 Hour | 1.7 score on a scale | Standard Deviation 0.58 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase | Dose 4, 0 Hour | 3.0 score on a scale | Standard Deviation 1.41 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase | Dose 5, 0 Hour | 2.5 score on a scale | Standard Deviation 0.71 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase | Dose 6, 0 Hour | 2.0 score on a scale | — |
Primary
Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase
Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group, (0 = no pain and 10 = very much pain). Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 years and 0 years to \< 2 years age groups, (0 = no pain and 10 = very much pain). PID was calculated as the pain intensity score at baseline minus the current pain intensity score at each corresponding time point.
Time frame: Baseline (prior to dose); 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose; and at the time of rescue
Population: Effectiveness Population. The analyses performed for this study report did not differentiate the pain intensity and pain intensity difference by age/dose combination.~The analyses were conducted by age group alone and results are presented accordingly.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase | 12 Hours Post-Dose | 3.3 score on a scale | Standard Deviation 5.77 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase | 2 Hours Post-Dose | 1.5 score on a scale | Standard Deviation 4.03 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase | 8 Hours Post-Dose | 1.3 score on a scale | Standard Deviation 2.31 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase | 4 Hours Post-Dose | 2.7 score on a scale | Standard Deviation 4.21 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase | 3 Hours Post-Dose | 3.0 score on a scale | Standard Deviation 2 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase | 15 Minutes Post-Dose | 1.1 score on a scale | Standard Deviation 4.24 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase | 1 Hour Post-Dose | 2.4 score on a scale | Standard Deviation 3.67 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase | 30 Minutes Post-Dose | 1.6 score on a scale | Standard Deviation 3.33 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase | 6 Hours Post-Dose | 3.1 score on a scale | Standard Deviation 4.14 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase | 1.5 Hours Post-Dose | 3.0 score on a scale | Standard Deviation 3.86 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase | 3 Hours Post-Dose | -1.0 score on a scale | Standard Deviation 2 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase | 15 Minutes Post-Dose | 2.1 score on a scale | Standard Deviation 2.56 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase | 30 Minutes Post-Dose | 2.1 score on a scale | Standard Deviation 2.49 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase | 1 Hour Post-Dose | 2.6 score on a scale | Standard Deviation 3.1 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase | 1.5 Hours Post-Dose | 3.8 score on a scale | Standard Deviation 3.84 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase | 2 Hours Post-Dose | 2.6 score on a scale | Standard Deviation 3.4 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase | 4 Hours Post-Dose | 2.5 score on a scale | Standard Deviation 3.24 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase | 6 Hours Post-Dose | 3.0 score on a scale | Standard Deviation 2.4 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase | 8 Hours Post-Dose | 2.4 score on a scale | Standard Deviation 2.92 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase | 12 Hours Post-Dose | 3.2 score on a scale | Standard Deviation 2.32 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase | 24 Hours Post-Dose | 3.0 score on a scale | Standard Deviation 2.16 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase | 24 Hours Post-Dose | 0.0 score on a scale | Standard Deviation 0 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase | 6 Hours Post-Dose | 1.0 score on a scale | Standard Deviation 2.71 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase | 30 Minutes Post-Dose | 2.0 score on a scale | Standard Deviation 2.45 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase | 12 Hours Post-Dose | 1.7 score on a scale | Standard Deviation 2.89 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase | 8 Hours Post-Dose | 1.7 score on a scale | Standard Deviation 2.89 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase | 3 Hours Post-Dose | 2.0 score on a scale | Standard Deviation 2.31 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase | 2 Hours Post-Dose | 2.0 score on a scale | Standard Deviation 2.45 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase | 15 Minutes Post-Dose | 1.1 score on a scale | Standard Deviation 4.06 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase | 4 Hours Post-Dose | 1.0 score on a scale | Standard Deviation 2.83 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase | 1 Hour Post-Dose | 2.3 score on a scale | Standard Deviation 1.98 |
Primary
Number (%) of Subjects With Rescue Medication Use by Age and Dose Group in Multiple-Dose Phase
Rescue Medication Use in Multiple Dose Phase
Time frame: Rescue Medication Use
Population: Effectiveness Population.IDMC recommended dose: 0.20 mg/kg oxymorphone HCl oral solution for the Multiple-dose Phase. Therefore, the analyses were conducted in a total of 16 subjects ranging from 2 to ≤12 years who received the dose of 0.20 mg/kg oxymorphone HCl oral solution as shown in the table of baseline characteristic in the participant flow.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Number (%) of Subjects With Rescue Medication Use by Age and Dose Group in Multiple-Dose Phase | Rescue Medication Used | 5 Participants |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Number (%) of Subjects With Rescue Medication Use by Age and Dose Group in Multiple-Dose Phase | No Rescue Medication needed | 5 Participants |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Number (%) of Subjects With Rescue Medication Use by Age and Dose Group in Multiple-Dose Phase | Rescue Medication Used | 2 Participants |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Number (%) of Subjects With Rescue Medication Use by Age and Dose Group in Multiple-Dose Phase | No Rescue Medication needed | 4 Participants |
Primary
Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase
Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group, (0 = no pain and 10 = very much pain). Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 years and 0 years to \< 2 years age groups, (0 = no pain and 10 = very much pain)
Time frame: Baseline, 0.5, 1, 1.5, 2, hours post dose, and immediately prior to all remaining doses administered through 48 hours after administration of the initial dose; and at time of rescue
Population: Effectiveness Population. Based on the recommendation of the Independent Data Monitoring Committee (IDMC), there was only 1 dose group of 0.2 mg/kg administered during the Multiple-dose Phase. Thus, this outcome measure was only assessed in this dose group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase | Dose 1, Baseline (Prior to Treatment) | 3.1 score on a scale | Standard Deviation 2.67 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase | Dose 3, 0 Hour | 5.6 score on a scale | Standard Deviation 2.61 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase | Dose 4, 0 Hour | 4.0 score on a scale | Standard Deviation 3.58 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase | Dose 5, 0 Hour | 2.5 score on a scale | Standard Deviation 1 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase | Dose 6, 0 Hour | 2.5 score on a scale | Standard Deviation 1 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase | Dose 7, 0 Hour | 3.0 score on a scale | Standard Deviation 2 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase | Dose 8, 0 Hour | 4.7 score on a scale | Standard Deviation 2.31 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase | Dose 9, 0 Hour | 1.3 score on a scale | Standard Deviation 1.15 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase | Dose 10, 0 Hour | 2.0 score on a scale | Standard Deviation 0 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase | Dose 11, 0 Hour | 2.0 score on a scale | Standard Deviation 0 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase | Dose 12, 0 Hour | 5.0 score on a scale | Standard Deviation 4.24 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase | End of Study/Early Termination | 4.0 score on a scale | Standard Deviation 1.63 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase | Dose 1, 30 Minutes Post Dose | 2.7 score on a scale | Standard Deviation 1.73 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase | Dose 1, 1 Hour Post Dose | 2.0 score on a scale | Standard Deviation 2.83 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase | Dose 1, 1.5 Hours Post Dose | 2.3 score on a scale | Standard Deviation 1.67 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase | Dose 1, 2 Hours Post Dose | 2.8 score on a scale | Standard Deviation 2.38 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase | Dose 2, 0 Hour | 4.0 score on a scale | Standard Deviation 3.27 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase | Dose 1, Baseline (Prior to Treatment) | 3.5 score on a scale | Standard Deviation 3.27 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase | Dose 5, 0 Hour | 5.0 score on a scale | Standard Deviation 0 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase | Dose 1, 30 Minutes Post Dose | 1.3 score on a scale | Standard Deviation 1.97 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase | Dose 3, 0 Hour | 3.7 score on a scale | Standard Deviation 3.21 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase | Dose 1, 1 Hour Post Dose | 1.8 score on a scale | Standard Deviation 2.05 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase | End of Study/Early Termination | 1.3 score on a scale | Standard Deviation 2.5 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase | Dose 1, 1.5 Hours Post Dose | 0.0 score on a scale | Standard Deviation 0 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase | Dose 4, 0 Hour | 4.5 score on a scale | Standard Deviation 0.71 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase | Dose 1, 2 Hours Post Dose | 0.0 score on a scale | Standard Deviation 0 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase | Dose 6, 0 Hour | 6.0 score on a scale | — |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase | Dose 2, 0 Hour | 5.0 score on a scale | Standard Deviation 2.65 |
Primary
Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase
Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group, (0 = no pain and 10 = very much pain). Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 years and 0 years to \< 2 years age groups, (0 = no pain and 10 = very much pain).
Time frame: Baseline, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose; and at the time of rescue
Population: Effectiveness Population. The analyses performed for this study report did not differentiate the pain intensity and pain intensity difference by age/dose combination.~The analyses were conducted by age group alone and results are presented accordingly.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase | Baseline (Prior to Treatment) | 4.5 score on a scale | Standard Deviation 3.12 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase | 15 Minutes Post Dose | 3.5 score on a scale | Standard Deviation 3.64 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase | 30 Minutes Post Dose | 2.7 score on a scale | Standard Deviation 3.29 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase | 1 Hour Post Dose | 1.8 score on a scale | Standard Deviation 1.93 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase | 1.5 Hours Post Dose | 2.0 score on a scale | Standard Deviation 2.56 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase | 2 Hours Post Dose | 3.1 score on a scale | Standard Deviation 3.37 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase | 3 Hours Post Dose | 0.0 score on a scale | Standard Deviation 0 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase | 4 Hours Post Dose | 1.8 score on a scale | Standard Deviation 2.17 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase | 6 Hours Post Dose | 2.3 score on a scale | Standard Deviation 1.8 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase | 8 Hours Post Dose | 3.3 score on a scale | Standard Deviation 5.77 |
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase | 12 Hours Post Dose | 1.3 score on a scale | Standard Deviation 2.31 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase | 8 Hours Post Dose | 0.8 score on a scale | Standard Deviation 1.39 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase | Baseline (Prior to Treatment) | 3.4 score on a scale | Standard Deviation 3.55 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase | 3 Hours Post Dose | 2.0 score on a scale | Standard Deviation 2.65 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase | 6 Hours Post Dose | 0.7 score on a scale | Standard Deviation 1.41 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase | 15 Minutes Post Dose | 1.2 score on a scale | Standard Deviation 2.5 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase | 2 Hours Post Dose | 0.4 score on a scale | Standard Deviation 0.81 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase | 12 Hours Post Dose | 0.0 score on a scale | Standard Deviation 0 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase | 30 Minutes Post Dose | 1.2 score on a scale | Standard Deviation 2.28 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase | 4 Hours Post Dose | 1.5 score on a scale | Standard Deviation 2.34 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase | 24 Hours Post Dose | 0.0 score on a scale | Standard Deviation 0 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase | 1 Hour Post Dose | 0.2 score on a scale | Standard Deviation 0.56 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase | 1.5 Hours Post Dose | 0.2 score on a scale | Standard Deviation 0.6 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase | 4 Hours Post Dose | 1.3 score on a scale | Standard Deviation 1.51 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase | 8 Hours Post Dose | 0.0 score on a scale | Standard Deviation 0 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase | 2 Hours Post Dose | 0.4 score on a scale | Standard Deviation 0.79 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase | 24 Hours Post Dose | 0.0 score on a scale | Standard Deviation 0 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase | 3 Hours Post Dose | 0.4 score on a scale | Standard Deviation 1.13 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase | 1 Hour Post Dose | 0.1 score on a scale | Standard Deviation 0.38 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase | 12 Hours Post Dose | 0.0 score on a scale | Standard Deviation 0 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase | Baseline (Prior to Treatment) | 2.4 score on a scale | Standard Deviation 1.9 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase | 15 Minutes Post Dose | 1.3 score on a scale | Standard Deviation 2.63 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase | 6 Hours Post Dose | 0.8 score on a scale | Standard Deviation 1.5 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase | 30 Minutes Post Dose | 0.4 score on a scale | Standard Deviation 0.79 |
Secondary
6 Beta-Hydroxyoxymorphone AUC0-24 Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
Time frame: Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone AUC0-24 Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 2.11 h*ng/mL | Standard Deviation 0.748 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone AUC0-24 Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 1.78 h*ng/mL | Standard Deviation 1.72 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone AUC0-24 Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 7.38 h*ng/mL | — |
Secondary
6 Beta-Hydroxyoxymorphone AUC0-24 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
Time frame: Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose
Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone AUC0-24 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 1.09 h*ng/mL | — |
| 2 Years to < 6 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone AUC0-24 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 1.09 h*ng/mL | — |
| 0 Years to < 2 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone AUC0-24 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 1.08 h*ng/mL | Standard Deviation 0.484 |
| 0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose | 6 Beta-Hydroxyoxymorphone AUC0-24 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 1.45 h*ng/mL | Standard Deviation 0.588 |
| 0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose | 6 Beta-Hydroxyoxymorphone AUC0-24 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 3.08 h*ng/mL | Standard Deviation 1.32 |
| 0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose | 6 Beta-Hydroxyoxymorphone AUC0-24 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 2.61 h*ng/mL | Standard Deviation 0.226 |
Secondary
6 Beta-Hydroxyoxymorphone AUC0-inf Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
Time frame: Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone AUC0-inf Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 2.15 h*ng/mL | Standard Deviation 0.769 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone AUC0-inf Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 1.79 h*ng/mL | Standard Deviation 1.73 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone AUC0-inf Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 7.66 h*ng/mL | — |
Secondary
6 Beta-Hydroxyoxymorphone AUC0-inf Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
Time frame: Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose
Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone AUC0-inf Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 1.83 h*ng/mL | — |
| 2 Years to < 6 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone AUC0-inf Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 1.11 h*ng/mL | — |
| 0 Years to < 2 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone AUC0-inf Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 0.535 h*ng/mL | — |
| 0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose | 6 Beta-Hydroxyoxymorphone AUC0-inf Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 1.76 h*ng/mL | Standard Deviation 0.762 |
| 0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose | 6 Beta-Hydroxyoxymorphone AUC0-inf Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 7.58 h*ng/mL | Standard Deviation 5.12 |
| 0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose | 6 Beta-Hydroxyoxymorphone AUC0-inf Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 2.76 h*ng/mL | Standard Deviation 0.399 |
Secondary
6 Beta-Hydroxyoxymorphone AUC0-t Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
Time frame: Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
Population: Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of AUC0-t was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone AUC0-t Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 1.35 h*ng/mL | Standard Deviation 1.27 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone AUC0-t Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 1.61 h*ng/mL | Standard Deviation 1.19 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone AUC0-t Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 2.25 h*ng/mL | Standard Deviation 0.547 |
Secondary
6 Beta-Hydroxyoxymorphone AUC0-t Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
Time frame: Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose
Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone AUC0-t Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 0.459 h*ng/mL | Standard Deviation 0.396 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone AUC0-t Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 0.467 h*ng/mL | Standard Deviation 0.473 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone AUC0-t Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 1.22 h*ng/mL | Standard Deviation 0.761 |
| 0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose | 6 Beta-Hydroxyoxymorphone AUC0-t Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 1.27 h*ng/mL | Standard Deviation 0.637 |
| 0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose | 6 Beta-Hydroxyoxymorphone AUC0-t Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 2.64 h*ng/mL | Standard Deviation 2.52 |
| 0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose | 6 Beta-Hydroxyoxymorphone AUC0-t Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 2.26 h*ng/mL | Standard Deviation 1.07 |
Secondary
6 Beta-Hydroxyoxymorphone Clast Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
Time frame: Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
Population: Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Clast was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone Clast Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 0.201 ng/mL | Standard Deviation 0.118 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone Clast Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 0.225 ng/mL | Standard Deviation 0.139 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone Clast Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 1.25 ng/mL | Standard Deviation 0.585 |
Secondary
6 Beta-Hydroxyoxymorphone Clast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase
Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
Time frame: Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose
Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone Clast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 0.0453 ng/mL | Standard Deviation 0.0272 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone Clast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 0.0418 ng/mL | Standard Deviation 0.0152 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone Clast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 0.0568 ng/mL | Standard Deviation 0.0292 |
| 0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose | 6 Beta-Hydroxyoxymorphone Clast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 0.0332 ng/mL | Standard Deviation 0.0183 |
| 0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose | 6 Beta-Hydroxyoxymorphone Clast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 0.204 ng/mL | Standard Deviation 0.188 |
| 0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose | 6 Beta-Hydroxyoxymorphone Clast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 0.0994 ng/mL | Standard Deviation 0.144 |
Secondary
6 Beta-Hydroxyoxymorphone Cmax Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Time frame: Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
Population: Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Cmax was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone Cmax Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 0.547 ng/mL | Standard Deviation 0.472 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone Cmax Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 0.829 ng/mL | Standard Deviation 0.541 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone Cmax Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 1.41 ng/mL | Standard Deviation 0.473 |
Secondary
6 Beta-Hydroxyoxymorphone Cmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Time frame: Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose
Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone Cmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 0.104 ng/mL | Standard Deviation 0.0555 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone Cmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 0.1 ng/mL | Standard Deviation 0.073 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone Cmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 0.384 ng/mL | Standard Deviation 0.177 |
| 0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose | 6 Beta-Hydroxyoxymorphone Cmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 0.437 ng/mL | Standard Deviation 0.419 |
| 0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose | 6 Beta-Hydroxyoxymorphone Cmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 0.603 ng/mL | Standard Deviation 0.513 |
| 0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose | 6 Beta-Hydroxyoxymorphone Cmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 0.587 ng/mL | Standard Deviation 0.182 |
Secondary
6 Beta-Hydroxyoxymorphone t1/2 Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
t1/2: Terminal half-life, calculated as λn/(ln 2)
Time frame: Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone t1/2 Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 3.61 h | Standard Deviation 1.67 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone t1/2 Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 1.42 h | Standard Deviation 0.73 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone t1/2 Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 4.9 h | — |
Secondary
6 Beta-Hydroxyoxymorphone t1/2 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase
t1/2: Terminal half-life, calculated as λn/(ln 2)
Time frame: Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose
Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone t1/2 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 20.5 h | — |
| 2 Years to < 6 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone t1/2 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 4.48 h | — |
| 0 Years to < 2 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone t1/2 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 2.31 h | — |
| 0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose | 6 Beta-Hydroxyoxymorphone t1/2 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 8.67 h | Standard Deviation 8.06 |
| 0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose | 6 Beta-Hydroxyoxymorphone t1/2 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 18.7 h | Standard Deviation 22.5 |
| 0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose | 6 Beta-Hydroxyoxymorphone t1/2 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 5.18 h | Standard Deviation 2.55 |
Secondary
6 Beta-Hydroxyoxymorphone Tlast Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
Tlast: The time at which Clast was observed
Time frame: Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
Population: Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Tlast was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone Tlast Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 3.97 h | Standard Deviation 1.05 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone Tlast Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 4.47 h | Standard Deviation 1.68 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone Tlast Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 2.09 h | Standard Deviation 0.077 |
Secondary
6 Beta-Hydroxyoxymorphone Tlast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase
Tlast: The time at which Clast was observed
Time frame: Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose
Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone Tlast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 9.66 h | Standard Deviation 8.25 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone Tlast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 8.86 h | Standard Deviation 7.82 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone Tlast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 14.4 h | Standard Deviation 7.86 |
| 0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose | 6 Beta-Hydroxyoxymorphone Tlast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 16.1 h | Standard Deviation 9.05 |
| 0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose | 6 Beta-Hydroxyoxymorphone Tlast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 12.6 h | Standard Deviation 9.85 |
| 0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose | 6 Beta-Hydroxyoxymorphone Tlast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 18.4 h | Standard Deviation 8.97 |
Secondary
6 Beta-Hydroxyoxymorphone Tmax Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
Tmax: The time at which Cmax was observed
Time frame: Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
Population: Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Tmax was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone Tmax Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 1.67 h | Standard Deviation 1.01 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone Tmax Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 1.37 h | Standard Deviation 1.5 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone Tmax Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 1.36 h | Standard Deviation 0.85 |
Secondary
6 Beta-Hydroxyoxymorphone Tmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase
Tmax: The time at which Cmax was observed
Time frame: Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose
Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone Tmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 2.86 h | Standard Deviation 1.17 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone Tmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 2.91 h | Standard Deviation 1.11 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | 6 Beta-Hydroxyoxymorphone Tmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 1.38 h | Standard Deviation 1.3 |
| 0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose | 6 Beta-Hydroxyoxymorphone Tmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 1.86 h | Standard Deviation 1.69 |
| 0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose | 6 Beta-Hydroxyoxymorphone Tmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 3.08 h | Standard Deviation 3.42 |
| 0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose | 6 Beta-Hydroxyoxymorphone Tmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 1.93 h | Standard Deviation 1.71 |
Secondary
Dose-Normalized 6 Beta-Hydroxyoxymorphone CL/F Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase
CL/F: Apparent oral clearance, calculated as Dose/AUC0-inf
Time frame: Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose
Population: PK Population (subjects with sufficient plasma concentration data to calculate PK parameter values). Since the overall exposure (AUC 0 to t) increased in near dose proportional manner, PK parameter values were dose normalized across all dose levels for each age group to determine the CL/F.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Dose-Normalized 6 Beta-Hydroxyoxymorphone CL/F Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 70.7 L/h/kg | Standard Deviation 78.8 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Dose-Normalized 6 Beta-Hydroxyoxymorphone CL/F Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 65 L/h/kg | Standard Deviation 23.2 |
Secondary
Dose-Normalized 6 Beta-Hydroxyoxymorphone V/F Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase
V/F: Apparent volume of distribution, calculated as Dose/(AUC0-inf \* λn)
Time frame: Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose
Population: PK Population (subjects with sufficient plasma concentration data to calculate PK parameter values). Since the overall exposure (AUC 0 to t) increased in near dose proportional manner, PK parameter values were dose normalized across all dose levels for each age group to determine the V/F.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Dose-Normalized 6 Beta-Hydroxyoxymorphone V/F Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 631 L/kg | Standard Deviation 308 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Dose-Normalized 6 Beta-Hydroxyoxymorphone V/F Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 575 L/kg | Standard Deviation 487 |
Secondary
Dose-Normalized Oxymorphone CL/F Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase
CL/F: Apparent oral clearance, calculated as Dose/AUC0-inf
Time frame: Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose
Population: PK Population (subjects with sufficient plasma concentration data to calculate PK parameter values). Since the overall exposure (AUC 0 to t) increased in near dose proportional manner, PK parameter values were dose normalized across all dose levels for each age group to determine the CL/F.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Dose-Normalized Oxymorphone CL/F Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 31.2 L/h/kg | Standard Deviation 13.6 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Dose-Normalized Oxymorphone CL/F Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 26.4 L/h/kg | Standard Deviation 18.8 |
Secondary
Dose-Normalized Oxymorphone V/F Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase
V/F: Apparent volume of distribution, calculated as Dose/(AUC0-inf \* λn)
Time frame: Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose
Population: PK Population (subjects with sufficient plasma concentration data to calculate PK parameter values). Since the overall exposure (AUC 0 to t) increased in near dose proportional manner, PK parameter values were dose normalized across all dose levels for each age group to determine the V/F.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Dose-Normalized Oxymorphone V/F Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 205 L/kg | Standard Deviation 145 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Dose-Normalized Oxymorphone V/F Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 154 L/kg | Standard Deviation 121 |
Secondary
Oxymorphone AUC0-24 Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
Time frame: Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Oxymorphone AUC0-24 Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 4.01 h*ng/mL | Standard Deviation 1.42 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Oxymorphone AUC0-24 Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 4.53 h*ng/mL | Standard Deviation 2.21 |
Secondary
Oxymorphone AUC0-24 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase
AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
Time frame: Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose
Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Oxymorphone AUC0-24 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 3.75 h*ng/mL | Standard Deviation 2.32 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Oxymorphone AUC0-24 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 2.65 h*ng/mL | Standard Deviation 1.4 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | Oxymorphone AUC0-24 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 3.01 h*ng/mL | Standard Deviation 0.905 |
| 0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose | Oxymorphone AUC0-24 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 3.69 h*ng/mL | Standard Deviation 2.44 |
| 0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose | Oxymorphone AUC0-24 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 6.11 h*ng/mL | Standard Deviation 2.83 |
| 0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose | Oxymorphone AUC0-24 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 14 h*ng/mL | Standard Deviation 4.72 |
Secondary
Oxymorphone AUC0-inf Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
Time frame: Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Oxymorphone AUC0-inf Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 4.01 h*ng/mL | Standard Deviation 1.43 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Oxymorphone AUC0-inf Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 4.53 h*ng/mL | Standard Deviation 2.21 |
Secondary
Oxymorphone AUC0-inf Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase
AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
Time frame: Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose
Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Oxymorphone AUC0-inf Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | NA h*ng/mL | Standard Deviation 0.0516 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Oxymorphone AUC0-inf Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 3.22 h*ng/mL | Standard Deviation 1.56 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | Oxymorphone AUC0-inf Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 3.01 h*ng/mL | Standard Deviation 0.946 |
| 0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose | Oxymorphone AUC0-inf Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 3.69 h*ng/mL | Standard Deviation 3.12 |
| 0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose | Oxymorphone AUC0-inf Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 6.92 h*ng/mL | Standard Deviation 4.02 |
| 0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose | Oxymorphone AUC0-inf Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 14.3 h*ng/mL | Standard Deviation 5.01 |
Secondary
Oxymorphone AUC0-t Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
Time frame: Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
Population: Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of AUC0-t was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Oxymorphone AUC0-t Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 3.49 h*ng/mL | Standard Deviation 3.22 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Oxymorphone AUC0-t Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 3.88 h*ng/mL | Standard Deviation 1.45 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | Oxymorphone AUC0-t Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 4.24 h*ng/mL | Standard Deviation 0.9 |
Secondary
Oxymorphone AUC0-t Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase
AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
Time frame: Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose
Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Oxymorphone AUC0-t Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 2.56 h*ng/mL | Standard Deviation 2 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Oxymorphone AUC0-t Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 1.69 h*ng/mL | Standard Deviation 0.943 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | Oxymorphone AUC0-t Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 3.01 h*ng/mL | Standard Deviation 0.766 |
| 0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose | Oxymorphone AUC0-t Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 3.99 h*ng/mL | Standard Deviation 2.09 |
| 0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose | Oxymorphone AUC0-t Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 5.32 h*ng/mL | Standard Deviation 4.53 |
| 0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose | Oxymorphone AUC0-t Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 9.37 h*ng/mL | Standard Deviation 5.81 |
Secondary
Oxymorphone Clast Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
Time frame: Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
Population: Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Clast was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Oxymorphone Clast Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 0.452 ng/mL | Standard Deviation 0.286 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Oxymorphone Clast Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 0.508 ng/mL | Standard Deviation 0.32 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | Oxymorphone Clast Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 2.3 ng/mL | Standard Deviation 0.745 |
Secondary
Oxymorphone Clast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase
Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
Time frame: Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose
Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Oxymorphone Clast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 0.0759 ng/mL | Standard Deviation 0.072 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Oxymorphone Clast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 0.0618 ng/mL | Standard Deviation 0.0389 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | Oxymorphone Clast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 0.11 ng/mL | Standard Deviation 0.0847 |
| 0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose | Oxymorphone Clast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 0.0671 ng/mL | Standard Deviation 0.0376 |
| 0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose | Oxymorphone Clast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 0.269 ng/mL | Standard Deviation 0.182 |
| 0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose | Oxymorphone Clast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 0.645 ng/mL | Standard Deviation 1.3 |
Secondary
Oxymorphone Cmax Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Time frame: Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
Population: Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Cmax was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Oxymorphone Cmax Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 1.46 ng/mL | Standard Deviation 1.16 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Oxymorphone Cmax Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 2.58 ng/mL | Standard Deviation 1.24 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | Oxymorphone Cmax Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 2.66 ng/mL | Standard Deviation 0.805 |
Secondary
Oxymorphone Cmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase
Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Time frame: Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose
Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Oxymorphone Cmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 0.415 ng/mL | Standard Deviation 0.211 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Oxymorphone Cmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 0.33 ng/mL | Standard Deviation 0.217 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | Oxymorphone Cmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 1.14 ng/mL | Standard Deviation 0.847 |
| 0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose | Oxymorphone Cmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 1.76 ng/mL | Standard Deviation 1.62 |
| 0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose | Oxymorphone Cmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 1.33 ng/mL | Standard Deviation 0.772 |
| 0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose | Oxymorphone Cmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 3.16 ng/mL | Standard Deviation 1.65 |
Secondary
Oxymorphone t1/2 Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
t1/2: Terminal half-life, calculated as λn/(ln 2)
Time frame: Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Oxymorphone t1/2 Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 2.18 h | Standard Deviation 0.459 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Oxymorphone t1/2 Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 1.17 h | Standard Deviation 0.632 |
Secondary
Oxymorphone t1/2 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase
t1/2: Terminal half-life, calculated as λn/(ln 2)
Time frame: Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose
Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Oxymorphone t1/2 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | NA h | Standard Deviation 0.232 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Oxymorphone t1/2 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 5.01 h | Standard Deviation 1.4 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | Oxymorphone t1/2 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 7.5 h | Standard Deviation 7.33 |
| 0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose | Oxymorphone t1/2 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 4.38 h | Standard Deviation 2.9 |
| 0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose | Oxymorphone t1/2 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 5.13 h | Standard Deviation 3.16 |
| 0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose | Oxymorphone t1/2 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 4.39 h | Standard Deviation 1.16 |
Secondary
Oxymorphone Tlast Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
Tlast: The time at which Clast was observed
Time frame: Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
Population: Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Tlast was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Oxymorphone Tlast Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 4 h | Standard Deviation 0.971 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Oxymorphone Tlast Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 4.47 h | Standard Deviation 1.68 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | Oxymorphone Tlast Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 2.09 h | Standard Deviation 0.077 |
Secondary
Oxymorphone Tlast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase
Tlast: The time at which Clast was observed
Time frame: Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose
Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Oxymorphone Tlast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 15.4 h | Standard Deviation 7.01 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Oxymorphone Tlast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 13.2 h | Standard Deviation 5.06 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | Oxymorphone Tlast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 18 h | Standard Deviation 6.55 |
| 0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose | Oxymorphone Tlast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 16 h | Standard Deviation 8.04 |
| 0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose | Oxymorphone Tlast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 12.6 h | Standard Deviation 9.85 |
| 0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose | Oxymorphone Tlast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 18.4 h | Standard Deviation 8.97 |
Secondary
Oxymorphone Tmax Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
Tmax: The time at which Cmax was observed
Time frame: Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7
Population: Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Tmax was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Oxymorphone Tmax Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 1.37 h | Standard Deviation 0.599 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Oxymorphone Tmax Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 0.967 h | Standard Deviation 0.622 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | Oxymorphone Tmax Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7 | 1.21 h | Standard Deviation 1.1 |
Secondary
Oxymorphone Tmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase
Tmax: The time at which Cmax was observed
Time frame: Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose
Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Years to ≤ 12 Years Age Group in Single Dose Phase | Oxymorphone Tmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 2.7 h | Standard Deviation 1.66 |
| 2 Years to < 6 Years Age Group in Single Dose Phase | Oxymorphone Tmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 2.64 h | Standard Deviation 1.03 |
| 0 Years to < 2 Years Age Group in Single Dose Phase | Oxymorphone Tmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 1.38 h | Standard Deviation 1.3 |
| 0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose | Oxymorphone Tmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 1.45 h | Standard Deviation 1.39 |
| 0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose | Oxymorphone Tmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 2.49 h | Standard Deviation 3.17 |
| 0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose | Oxymorphone Tmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase | 1.59 h | Standard Deviation 1.38 |