Chronic Pain, Opioid Use Disorder
Conditions
Brief summary
Phase II, open label, partially randomized, three treatment group study designed to evaluate the steady state pharmacokinetics of buprenorphine and norbuprenorphine following repeated subcutaneous administrations of CAM2038.
Detailed description
This is a phase II, open label, partially randomized, three treatment group study designed to evaluate the steady state pharmacokinetics of buprenorphine and norbuprenorphine following repeated subcutaneous administrations of CAM2038 weekly and monthly at different injection sites and to evaluate the steady state pharmacokinetics of buprenorphine and norbuprenorphine after repeated subcutaneous administration of CAM2038 monthly in opioid dependent subjects with a history of chronic non cancer pain. The study will involve three phases: Screening, Treatment, and Follow up.
Interventions
DRUGCAM2038
Long-Acting Subcutaneous Injectable Depot of Buprenorphine
Sponsors
Braeburn Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Subject must provide written informed consent prior to the conduct of any study related procedures. 2. Male or non pregnant, non lactating female subject, aged 19 to 65 years, inclusive. 3. Body mass index between 19 and 35 kg/m2, inclusive. 4. Current diagnosis of moderate to severe opioid use disorder (according to the DSM 5) or past medical history of opioid use disorder currently being treated with SL BPN. 5. Subject must be taking SL BPN (Subutex® equivalent) 24 mg (Group 1 and Group 2) or ≥24 mg (Group 3) daily for at least 30 days prior to Screening. 6. Subject has a history of moderate to severe chronic non cancer pain. 7. Male and female subjects of childbearing potential must be willing to use a reliable method of contraception during the entire study (Screening visit to Follow-up phone call). 8. Subject must be willing and able to comply with all study procedures and requirements.
Exclusion criteria
1. Individuals meeting DSM-V substance use disorder criteria for alcohol, benzodiazepines, central nervous system (CNS) stimulants, or other drugs of abuse (excluding caffeine, tobacco or THC/marijuana). 2. Any clinically significant abnormality on the basis of medical history, vital signs, physical examination, 12-lead electrocardiogram (ECG; Fridericia's corrected QT interval \[QTcF\] ≥450 msec. for males or ≥470 msec. for females), and laboratory evaluations (including hematology, clinical chemistry, urinalysis at Screening), in the opinion of the Investigator. 3. Significant symptoms, medical conditions, or other circumstances which, in the opinion of the Investigator, would preclude compliance with the protocol, adequate cooperation in the study or obtaining informed consent, or may prevent the subject from safely participating in study, including subjects who are at a risk for gastrointestinal obstruction or paralytic ileus or who have severe respiratory insufficiency, respiratory depression, airway obstruction, gastrointestinal motility disorders, biliary tract disease, severe hepatic insufficiency, planned surgery and prior treatment with monoamine oxidase inhibitors. 4. Use (therapeutic or non-therapeutic) of opioids other than SL BPN. 5. Aspartate aminotransferase (AST) levels \> 3 X the upper limit of normal, alanine aminotransferase (ALT), levels \> 3 X the upper limit of normal, total bilirubin \> 1.5 X the upper limit of normal, or creatinine \> 1.5 X upper limit of normal on the Screening laboratory assessments, or other clinically significant laboratory abnormalities, which in the opinion of the Investigator may prevent the subject from safely participating in study. 6. Pregnant or lactating or planning to become pregnant during the study. 7. Diagnosis of, or currently under investigation for, fibromyalgia, complex regional pain syndrome, neurogenic claudication due to spinal stenosis, spinal cord compression, acute nerve root compression, severe or progressive lower extremity weakness or numbness. 8. History of chemotherapy or confirmed malignancy (except basal cell or squamous carcinoma of the skin) within the past 2 years. 9. Clinically significant history of, or current evidence for, suicidal ideation or those who are actively suicidal, as based on the Columbia-Suicide Severity Rating Scale (C-SSRS; grade 4 or 5). 10. Clinically significant history of major depressive disorder that is poorly controlled with medication. 11. Hypersensitivity or allergy to BPN or other opioids, or excipients of CAM2038. 12. Exposure to any investigational drug within the 4 weeks prior to Screening. 13. Participants with a clinically significant history of risk factors of Torsades de Pointes and any existing ventricular tachyarrhythmias such as bigeminy, trigeminy, heart failure, hypokalemia, family history of Long QT Syndrome. 14. On medications that have the potential for prolonging the QT interval or who may require such medications during the course of the study along with clinically significant abnormalities on screening electrocardiogram (ECG) readings as deemed by the investigator. 15. Requires current use of agents that are strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) such as some azole antifungals (e.g., ketoconazole), macrolide antibiotics (e.g., clarithromycin), or protease inhibitors (e.g., ritonavir, indinavir, and saquinavir). 16. Intolerance to venipuncture and/or difficulty with venous access, as per the judgment of the Investigator/research staff. 17. Is an employee of the Investigator or the study site, with direct involvement in the proposed study or other studies under the direction of the Investigator or study site, or is a family member of an employee or of the Investigator. 18. Any pending legal action that could prohibit participation or compliance in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Maximum Concentration at Steady State-Norbuprenorphine | PK samples at pre-dose, 0.5, 1, 2, 4, 6,10 hrs and approx. 24, 48, 72, 96, 120, 168, 240, 336, 504 and 672 hrs after CAM2038 q4w Dose 4 and pre-dose (within 45 mins), 10, 20, 30 and 40 mins, and 1, 1.5, 2, 3, 4, 6, 10, and 24 hrs after SL BPN dose 7 | Time to maximum concentration at steady state-Norbuprenorphine-Pharmacokinetic (PK) Population |
| Norbuprenorphine/Buprenorphine Ratios for Area Under the Curve at Steady State | PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7. | Norbuprenorphine/buprenorphine ratios for Area Under the Curve at steady state Evaluable Pharmacokinetic (PKEVAL) Population |
| Area Under the Curve at Steady State (AUC During a 28-day Dosing Interval at Steady State)-Norepinephrine | PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4 | Area Under the Curve at steady state (AUC during a 28-day dosing interval at steady state)-Norepinephrine-Pharmacokinetic (PK) Population |
| Average Steady State Concentration-Norbuprenorphine | PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4 | Average steady state concentration-Norbuprenorphine-Pharmacokinetic (PK) Population |
| Maximum Steady State Concentration-Norbuprenorphine | PK samples at pre-dose, 0.5, 1, 2, 4, 6,10 hrs and approx. 24, 48, 72, 96, 120, 168, 240, 336, 504 and 672 hrs after CAM2038 q4w Dose 4 and pre-dose (within 45 mins), 10, 20, 30 and 40 mins, and 1, 1.5, 2, 3, 4, 6, 10, and 24 hrs after SL BPN dose 7 | Maximum steady state concentration-Norbuprenorphine-Pharmacokinetic (PK) Population |
| AUCss(Area Under the Plasma Concentration-time Curve During a 7-day Dosing Interval at Steady State) for Each Injection Site, i.e., Buttock (Reference), Abdomen, Thigh and Back of Upper Arm for the Evaluable Pharmacokinetic (PKEVAL) Population | PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7. | AUCss (area under the plasma concentration-time curve during a 7-day dosing interval at steady state) for each injection site, i.e., buttock (reference), abdomen, thigh and back of upper arm-Buprenorphine for the Evaluable Pharmacokinetic (PKEVAL) Population |
| Css,av(Average Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site for the Evaluable Pharmacokinetic (PKEVAL) Population | PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7. | Css,av (average plasma concentration during a dosing interval at steady state) for each injection site-Buprenorphine for the Evaluable Pharmacokinetic (PKEVAL) Population |
| Css,Max (Maximum Observed Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site. | PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7. | Css,max (maximum observed plasma concentration during a dosing interval at steady state) for each injection site-Buprenorphine |
| Tss,Max (Time to Maximum Concentration at Steady State) for Each Injection Site | PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7. | Tss,max (time to maximum concentration at steady state) for each injection site-buprenorphine |
| Area Under the Curve at Steady State (AUC During a 28-day Dosing Interval at Steady State)-Buprenorphine | PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4 | Area Under the Curve at steady state (AUC during a 28-day dosing interval at steady state)-Buprenorphine for Pharmacokinetic Population |
| Average Steady State Concentration-Buprenorphine | PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4 | Average steady state concentration-Buprenorphine-Pharmacokinetic Population |
| Maximum Steady State Concentration-Buprenorphine | PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4 | Maximum steady state concentration-BuprenorphinePharmacokinetic (PK) Population |
| Time to Maximum Concentration at Steady State-Buprenorphine | PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4 | Time to maximum concentration at steady state-Buprenorphine Pharmacokinetic (PK) Population |
| Norbuprenorphine/Buprenorphine Ratios at Maximum Concentration at Steady State | PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7. | Norbuprenorphine/buprenorphine ratios at maximum concentration at steady state Evaluable Pharmacokinetic (PKEVAL) Population |
| AUCss(Area Under the Plasma Concentration-time Curve During a 7-day Dosing Interval at Steady State) for Each Injection Site, i.e., Buttock (Reference), Abdomen, Thigh and Back of Upper Arm. | PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7. | AUCss (area under the plasma concentration-time curve during a 7-day dosing interval at steady state) for each injection site, i.e., buttock (reference), abdomen, thigh and back of upper arm-Norbuprenorphine Evaluable Pharmacokinetic (PKEVAL) Population |
| Css,av(Average Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site | PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7. | Css,av (average plasma concentration during a dosing interval at steady state) for each injection site-Norbuprenorphine-Evaluable Pharmacokinetic (PKEVAL) Population |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | 99 days for Group 1, 162 days for Group 2, 127 days for Group 3 | Number of Participants with Adverse Events for Both weekly and monthly CAM2038-Safety Population |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | 99 days for Group 1, 162 days for Group 2, 127 days for Group 3 | Number of Participants with confirmed Opiate Independence as confirmed by Negative Urine Toxicology Tests-ITT Population |
| Subject-rated Worst Daily Pain | 99 days for Group 1, 162 days for Group 2, 127 days for Group 3 | Subject-rated worst daily pain, using an 11-point numerical rating scale (NRS) for pain, following repeated subcutaneous administration of CAM2038 weekly and CAM2038 monthly in adult opioid-dependent subjects-Safety Population. 11 point scale ranging from 0-10, with 0 being the least amount of pain to 10 being the worst pain imaginable. |
| Summary of Average Daily Pain by Week (ITT Population) | 99 days for Group 1, 162 days for Group 2, 127 days for Group 3 | Summary of Average Daily Pain, using an 11-point Numerical Rating Scale (NRS) for pain, following repeated subcutaneous administration of CAM2038 weekly and CAM2038 monthly in adult opioid-dependent subjects. 11 point scale ranging from 0-10, with 0 being the least amount of pain to 10 being the worst pain imaginable. (ITT Population) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 32 mg CAM2038 Weekly Group 1, 32 mg of CAM2038 subcutaneous weekly injection at multiple injection sites
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine | 28 |
| 128 mg CAM2038 Monthly Injection Group 2: 128 mg of CAM2038 subcutaneous monthly injection in the buttocks
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine | 20 |
| 160 mg CAM2038 Monthly Injection Group 3: 24 mg SL BPN for the first 7 days and then 160 mg of CAM2038 subcutaneous monthly injection in the buttocks starting on Day 8
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine | 17 |
| Total | 65 |
Baseline characteristics
| Characteristic | 32 mg CAM2038 Weekly | 128 mg CAM2038 Monthly Injection | 160 mg CAM2038 Monthly Injection | Total |
|---|---|---|---|---|
| Age, Continuous | 44.2 years STANDARD_DEVIATION 10.83 | 48.0 years STANDARD_DEVIATION 11.49 | 44.1 years STANDARD_DEVIATION 12.23 | 45.3 years STANDARD_DEVIATION 11.37 |
| BMI | 26.0 kg/m^2 STANDARD_DEVIATION 3.95 | 27.0 kg/m^2 STANDARD_DEVIATION 4.25 | 28.3 kg/m^2 STANDARD_DEVIATION 3.72 | 26.9 kg/m^2 STANDARD_DEVIATION 4.04 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 20 Participants | 17 Participants | 64 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 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 |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 27 Participants | 20 Participants | 13 Participants | 60 Participants |
| Sex: Female, Male Female | 14 Participants | 4 Participants | 9 Participants | 27 Participants |
| Sex: Female, Male Male | 14 Participants | 16 Participants | 8 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 20 | 0 / 17 | 0 / 18 |
| other Total, other adverse events | 16 / 28 | 18 / 20 | 17 / 17 | 0 / 18 |
| serious Total, serious adverse events | 0 / 28 | 0 / 20 | 0 / 17 | 0 / 18 |
Outcome results
Primary
Area Under the Curve at Steady State (AUC During a 28-day Dosing Interval at Steady State)-Buprenorphine
Area Under the Curve at steady state (AUC during a 28-day dosing interval at steady state)-Buprenorphine for Pharmacokinetic Population
Time frame: PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4
Population: Pharmacokinetic (PK) Population consisted of all subjects in the Safety population who provided PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 32 mg CAM2038 Weekly-Buttock | Area Under the Curve at Steady State (AUC During a 28-day Dosing Interval at Steady State)-Buprenorphine | 2610 ng*h/mL | Geometric Coefficient of Variation 41.7 |
| 32 mg CAM2038 Weekly-Abdomen | Area Under the Curve at Steady State (AUC During a 28-day Dosing Interval at Steady State)-Buprenorphine | 3540 ng*h/mL | Geometric Coefficient of Variation 26.1 |
Primary
Area Under the Curve at Steady State (AUC During a 28-day Dosing Interval at Steady State)-Norepinephrine
Area Under the Curve at steady state (AUC during a 28-day dosing interval at steady state)-Norepinephrine-Pharmacokinetic (PK) Population
Time frame: PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4
Population: Pharmacokinetic (PK) Population consisted of all subjects in the Safety population who provided PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 32 mg CAM2038 Weekly-Buttock | Area Under the Curve at Steady State (AUC During a 28-day Dosing Interval at Steady State)-Norepinephrine | 795 ng*h/mL | Geometric Coefficient of Variation 130.5 |
| 32 mg CAM2038 Weekly-Abdomen | Area Under the Curve at Steady State (AUC During a 28-day Dosing Interval at Steady State)-Norepinephrine | 1590 ng*h/mL | Geometric Coefficient of Variation 55.1 |
Primary
AUCss(Area Under the Plasma Concentration-time Curve During a 7-day Dosing Interval at Steady State) for Each Injection Site, i.e., Buttock (Reference), Abdomen, Thigh and Back of Upper Arm.
AUCss (area under the plasma concentration-time curve during a 7-day dosing interval at steady state) for each injection site, i.e., buttock (reference), abdomen, thigh and back of upper arm-Norbuprenorphine Evaluable Pharmacokinetic (PKEVAL) Population
Time frame: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.
Population: Evaluable Pharmacokinetic (PKEVAL) Population consisted of all subjects who had sufficient PK data for all 4 randomized injection sites to derive PK parameters of interest
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 32 mg CAM2038 Weekly-Buttock | AUCss(Area Under the Plasma Concentration-time Curve During a 7-day Dosing Interval at Steady State) for Each Injection Site, i.e., Buttock (Reference), Abdomen, Thigh and Back of Upper Arm. | 204 ng*h/mL | Geometric Coefficient of Variation 70.5 |
| 32 mg CAM2038 Weekly-Abdomen | AUCss(Area Under the Plasma Concentration-time Curve During a 7-day Dosing Interval at Steady State) for Each Injection Site, i.e., Buttock (Reference), Abdomen, Thigh and Back of Upper Arm. | 192 ng*h/mL | Geometric Coefficient of Variation 69 |
| 32 mg CAM2038 Weekly-Thigh | AUCss(Area Under the Plasma Concentration-time Curve During a 7-day Dosing Interval at Steady State) for Each Injection Site, i.e., Buttock (Reference), Abdomen, Thigh and Back of Upper Arm. | 208 ng*h/mL | Geometric Coefficient of Variation 90.9 |
| 32 mg CAM2038 Weekly-Upper Arm | AUCss(Area Under the Plasma Concentration-time Curve During a 7-day Dosing Interval at Steady State) for Each Injection Site, i.e., Buttock (Reference), Abdomen, Thigh and Back of Upper Arm. | 197 ng*h/mL | Geometric Coefficient of Variation 70.1 |
Primary
AUCss(Area Under the Plasma Concentration-time Curve During a 7-day Dosing Interval at Steady State) for Each Injection Site, i.e., Buttock (Reference), Abdomen, Thigh and Back of Upper Arm for the Evaluable Pharmacokinetic (PKEVAL) Population
AUCss (area under the plasma concentration-time curve during a 7-day dosing interval at steady state) for each injection site, i.e., buttock (reference), abdomen, thigh and back of upper arm-Buprenorphine for the Evaluable Pharmacokinetic (PKEVAL) Population
Time frame: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.
Population: Evaluable Pharmacokinetic (PKEVAL) Population consisted of all subjects who had sufficient PK data for all 4 randomized injection sites to derive PK parameters of interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 32 mg CAM2038 Weekly-Buttock | AUCss(Area Under the Plasma Concentration-time Curve During a 7-day Dosing Interval at Steady State) for Each Injection Site, i.e., Buttock (Reference), Abdomen, Thigh and Back of Upper Arm for the Evaluable Pharmacokinetic (PKEVAL) Population | 700 ng*h/mL | Geometric Coefficient of Variation 27.1 |
| 32 mg CAM2038 Weekly-Abdomen | AUCss(Area Under the Plasma Concentration-time Curve During a 7-day Dosing Interval at Steady State) for Each Injection Site, i.e., Buttock (Reference), Abdomen, Thigh and Back of Upper Arm for the Evaluable Pharmacokinetic (PKEVAL) Population | 657 ng*h/mL | Geometric Coefficient of Variation 27.2 |
| 32 mg CAM2038 Weekly-Thigh | AUCss(Area Under the Plasma Concentration-time Curve During a 7-day Dosing Interval at Steady State) for Each Injection Site, i.e., Buttock (Reference), Abdomen, Thigh and Back of Upper Arm for the Evaluable Pharmacokinetic (PKEVAL) Population | 613 ng*h/mL | Geometric Coefficient of Variation 36.8 |
| 32 mg CAM2038 Weekly-Upper Arm | AUCss(Area Under the Plasma Concentration-time Curve During a 7-day Dosing Interval at Steady State) for Each Injection Site, i.e., Buttock (Reference), Abdomen, Thigh and Back of Upper Arm for the Evaluable Pharmacokinetic (PKEVAL) Population | 591 ng*h/mL | Geometric Coefficient of Variation 33.7 |
Primary
Average Steady State Concentration-Buprenorphine
Average steady state concentration-Buprenorphine-Pharmacokinetic Population
Time frame: PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4
Population: Pharmacokinetic (PK) Population consisted of all subjects in the Safety population who provided PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 32 mg CAM2038 Weekly-Buttock | Average Steady State Concentration-Buprenorphine | 3.89 ng/mL | Geometric Coefficient of Variation 41.7 |
| 32 mg CAM2038 Weekly-Abdomen | Average Steady State Concentration-Buprenorphine | 5.27 ng/mL | Geometric Coefficient of Variation 26.1 |
Primary
Average Steady State Concentration-Norbuprenorphine
Average steady state concentration-Norbuprenorphine-Pharmacokinetic (PK) Population
Time frame: PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4
Population: Pharmacokinetic (PK) Population consisted of all subjects in the Safety population who provided PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 32 mg CAM2038 Weekly-Buttock | Average Steady State Concentration-Norbuprenorphine | 1.18 ng/mL | Geometric Coefficient of Variation 130.5 |
| 32 mg CAM2038 Weekly-Abdomen | Average Steady State Concentration-Norbuprenorphine | 2.37 ng/mL | Geometric Coefficient of Variation 55.1 |
Primary
Css,av(Average Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site
Css,av (average plasma concentration during a dosing interval at steady state) for each injection site-Norbuprenorphine-Evaluable Pharmacokinetic (PKEVAL) Population
Time frame: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.
Population: Evaluable Pharmacokinetic (PKEVAL) Population consisted of all subjects who had sufficient PK data for all 4 randomized injection sites to derive PK parameters of interest
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 32 mg CAM2038 Weekly-Buttock | Css,av(Average Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site | 1.22 ng/mL | Geometric Coefficient of Variation 64.3 |
| 32 mg CAM2038 Weekly-Abdomen | Css,av(Average Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site | 1.15 ng/mL | Geometric Coefficient of Variation 69 |
| 32 mg CAM2038 Weekly-Thigh | Css,av(Average Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site | 1.24 ng/mL | Geometric Coefficient of Variation 90.9 |
| 32 mg CAM2038 Weekly-Upper Arm | Css,av(Average Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site | 1.17 ng/mL | Geometric Coefficient of Variation 70.1 |
Primary
Css,av(Average Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site for the Evaluable Pharmacokinetic (PKEVAL) Population
Css,av (average plasma concentration during a dosing interval at steady state) for each injection site-Buprenorphine for the Evaluable Pharmacokinetic (PKEVAL) Population
Time frame: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.
Population: Evaluable Pharmacokinetic (PKEVAL) Population consisted of all subjects who had sufficient PK data for all 4 randomized injection sites to derive PK parameters of interest
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 32 mg CAM2038 Weekly-Buttock | Css,av(Average Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site for the Evaluable Pharmacokinetic (PKEVAL) Population | 4.17 ng/mL | Geometric Coefficient of Variation 27.1 |
| 32 mg CAM2038 Weekly-Abdomen | Css,av(Average Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site for the Evaluable Pharmacokinetic (PKEVAL) Population | 3.91 ng/mL | Geometric Coefficient of Variation 27.2 |
| 32 mg CAM2038 Weekly-Thigh | Css,av(Average Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site for the Evaluable Pharmacokinetic (PKEVAL) Population | 3.65 ng/mL | Geometric Coefficient of Variation 36.8 |
| 32 mg CAM2038 Weekly-Upper Arm | Css,av(Average Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site for the Evaluable Pharmacokinetic (PKEVAL) Population | 3.52 ng/mL | Geometric Coefficient of Variation 33.7 |
Primary
Css,Max (Maximum Observed Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site.
Css,max (maximum observed plasma concentration during a dosing interval at steady state) for each injection site-Norbuprenorphine-Evaluable Pharmacokinetic (PKEVAL) Population
Time frame: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.
Population: Evaluable Pharmacokinetic (PKEVAL) Population consisted of all subjects who had sufficient PK data for all 4 randomized injection sites to derive PK parameters of interest
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 32 mg CAM2038 Weekly-Buttock | Css,Max (Maximum Observed Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site. | 1.85 ng/mL | Geometric Coefficient of Variation 74.5 |
| 32 mg CAM2038 Weekly-Abdomen | Css,Max (Maximum Observed Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site. | 1.78 ng/mL | Geometric Coefficient of Variation 67.2 |
| 32 mg CAM2038 Weekly-Thigh | Css,Max (Maximum Observed Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site. | 1.74 ng/mL | Geometric Coefficient of Variation 86.7 |
| 32 mg CAM2038 Weekly-Upper Arm | Css,Max (Maximum Observed Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site. | 1.84 ng/mL | Geometric Coefficient of Variation 78.2 |
Primary
Css,Max (Maximum Observed Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site.
Css,max (maximum observed plasma concentration during a dosing interval at steady state) for each injection site-Buprenorphine
Time frame: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.
Population: Evaluable Pharmacokinetic (PKEVAL) Population consisted of all subjects who had sufficient PK data for all 4 randomized injection sites to derive PK parameters of interest
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 32 mg CAM2038 Weekly-Buttock | Css,Max (Maximum Observed Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site. | 6.87 ng/mL | Geometric Coefficient of Variation 37.2 |
| 32 mg CAM2038 Weekly-Abdomen | Css,Max (Maximum Observed Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site. | 6.56 ng/mL | Geometric Coefficient of Variation 29.9 |
| 32 mg CAM2038 Weekly-Thigh | Css,Max (Maximum Observed Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site. | 5.37 ng/mL | Geometric Coefficient of Variation 43.6 |
| 32 mg CAM2038 Weekly-Upper Arm | Css,Max (Maximum Observed Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site. | 5.69 ng/mL | Geometric Coefficient of Variation 43.1 |
Primary
Maximum Steady State Concentration-Buprenorphine
Maximum steady state concentration-BuprenorphinePharmacokinetic (PK) Population
Time frame: PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4
Population: Pharmacokinetic (PK) Population consisted of all subjects in the Safety population who provided PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 32 mg CAM2038 Weekly-Buttock | Maximum Steady State Concentration-Buprenorphine | 11.1 ng/mL | Geometric Coefficient of Variation 54.1 |
| 32 mg CAM2038 Weekly-Abdomen | Maximum Steady State Concentration-Buprenorphine | 15.4 ng/mL | Geometric Coefficient of Variation 52 |
| 32 mg CAM2038 Weekly-Thigh | Maximum Steady State Concentration-Buprenorphine | 11.1 ng/mL | Geometric Coefficient of Variation 61.4 |
Primary
Maximum Steady State Concentration-Norbuprenorphine
Maximum steady state concentration-Norbuprenorphine-Pharmacokinetic (PK) Population
Time frame: PK samples at pre-dose, 0.5, 1, 2, 4, 6,10 hrs and approx. 24, 48, 72, 96, 120, 168, 240, 336, 504 and 672 hrs after CAM2038 q4w Dose 4 and pre-dose (within 45 mins), 10, 20, 30 and 40 mins, and 1, 1.5, 2, 3, 4, 6, 10, and 24 hrs after SL BPN dose 7
Population: Pharmacokinetic (PK) Population consisted of all subjects in the Safety population who provided PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 32 mg CAM2038 Weekly-Buttock | Maximum Steady State Concentration-Norbuprenorphine | 2.14 ng/mL | Geometric Coefficient of Variation 122.8 |
| 32 mg CAM2038 Weekly-Abdomen | Maximum Steady State Concentration-Norbuprenorphine | 4.61 ng/mL | Geometric Coefficient of Variation 54.5 |
| 32 mg CAM2038 Weekly-Thigh | Maximum Steady State Concentration-Norbuprenorphine | 7.92 ng/mL | Geometric Coefficient of Variation 75.6 |
Primary
Norbuprenorphine/Buprenorphine Ratios at Maximum Concentration at Steady State
Norbuprenorphine/buprenorphine ratios at maximum concentration at steady state Evaluable Pharmacokinetic (PKEVAL) Population
Time frame: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.
Population: Evaluable Pharmacokinetic (PKEVAL) Population consisted of all subjects who had sufficient PK data for all 4 randomized injection sites to derive PK parameters of interest
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 32 mg CAM2038 Weekly-Buttock | Norbuprenorphine/Buprenorphine Ratios at Maximum Concentration at Steady State | 0.305 ratio | Geometric Coefficient of Variation 59.1 |
| 32 mg CAM2038 Weekly-Abdomen | Norbuprenorphine/Buprenorphine Ratios at Maximum Concentration at Steady State | 0.307 ratio | Geometric Coefficient of Variation 53.9 |
| 32 mg CAM2038 Weekly-Thigh | Norbuprenorphine/Buprenorphine Ratios at Maximum Concentration at Steady State | 0.366 ratio | Geometric Coefficient of Variation 60.3 |
| 32 mg CAM2038 Weekly-Upper Arm | Norbuprenorphine/Buprenorphine Ratios at Maximum Concentration at Steady State | 0.366 ratio | Geometric Coefficient of Variation 55.2 |
Primary
Norbuprenorphine/Buprenorphine Ratios for Area Under the Curve at Steady State
Norbuprenorphine/buprenorphine ratios for Area Under the Curve at steady state Evaluable Pharmacokinetic (PKEVAL) Population
Time frame: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.
Population: Evaluable Pharmacokinetic (PKEVAL) Population consisted of all subjects who had sufficient PK data for all 4 randomized injection sites to derive PK parameters of interest
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 32 mg CAM2038 Weekly-Buttock | Norbuprenorphine/Buprenorphine Ratios for Area Under the Curve at Steady State | 0.354 ratio | Geometric Coefficient of Variation 57.4 |
| 32 mg CAM2038 Weekly-Abdomen | Norbuprenorphine/Buprenorphine Ratios for Area Under the Curve at Steady State | 0.341 ratio | Geometric Coefficient of Variation 52.5 |
| 32 mg CAM2038 Weekly-Thigh | Norbuprenorphine/Buprenorphine Ratios for Area Under the Curve at Steady State | 0.355 ratio | Geometric Coefficient of Variation 54.4 |
| 32 mg CAM2038 Weekly-Upper Arm | Norbuprenorphine/Buprenorphine Ratios for Area Under the Curve at Steady State | 0.370 ratio | Geometric Coefficient of Variation 50.7 |
Primary
Time to Maximum Concentration at Steady State-Buprenorphine
Time to maximum concentration at steady state-Buprenorphine Pharmacokinetic (PK) Population
Time frame: PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4
Population: Pharmacokinetic (PK) Population consisted of all subjects in the Safety population who provided PK data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 32 mg CAM2038 Weekly-Buttock | Time to Maximum Concentration at Steady State-Buprenorphine | 10.0 h |
| 32 mg CAM2038 Weekly-Abdomen | Time to Maximum Concentration at Steady State-Buprenorphine | 24.0 h |
| 32 mg CAM2038 Weekly-Thigh | Time to Maximum Concentration at Steady State-Buprenorphine | 1.69 h |
Primary
Time to Maximum Concentration at Steady State-Norbuprenorphine
Time to maximum concentration at steady state-Norbuprenorphine-Pharmacokinetic (PK) Population
Time frame: PK samples at pre-dose, 0.5, 1, 2, 4, 6,10 hrs and approx. 24, 48, 72, 96, 120, 168, 240, 336, 504 and 672 hrs after CAM2038 q4w Dose 4 and pre-dose (within 45 mins), 10, 20, 30 and 40 mins, and 1, 1.5, 2, 3, 4, 6, 10, and 24 hrs after SL BPN dose 7
Population: Pharmacokinetic (PK) Population consisted of all subjects in the Safety population who provided PK data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 32 mg CAM2038 Weekly-Buttock | Time to Maximum Concentration at Steady State-Norbuprenorphine | 84.1 h |
| 32 mg CAM2038 Weekly-Abdomen | Time to Maximum Concentration at Steady State-Norbuprenorphine | 121 h |
| 32 mg CAM2038 Weekly-Thigh | Time to Maximum Concentration at Steady State-Norbuprenorphine | 1.78 h |
Primary
Tss,Max (Time to Maximum Concentration at Steady State) for Each Injection Site
Tss,max (time to maximum concentration at steady state) for each injection site-buprenorphine
Time frame: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.
Population: Evaluable Pharmacokinetic (PKEVAL) Population consisted of all subjects who had sufficient PK data for all 4 randomized injection sites to derive PK parameters of interest
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 32 mg CAM2038 Weekly-Buttock | Tss,Max (Time to Maximum Concentration at Steady State) for Each Injection Site | 24.0 h |
| 32 mg CAM2038 Weekly-Abdomen | Tss,Max (Time to Maximum Concentration at Steady State) for Each Injection Site | 24.0 h |
| 32 mg CAM2038 Weekly-Thigh | Tss,Max (Time to Maximum Concentration at Steady State) for Each Injection Site | 24.0 h |
| 32 mg CAM2038 Weekly-Upper Arm | Tss,Max (Time to Maximum Concentration at Steady State) for Each Injection Site | 24.0 h |
Primary
Tss,Max (Time to Maximum Concentration at Steady State) for Each Injection Site
Tss,max (time to maximum concentration at steady state) for each injection site-Norbuprenorphine-Evaluable Pharmacokinetic (PKEVAL) Population
Time frame: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.
Population: Evaluable Pharmacokinetic (PKEVAL) Population consisted of all subjects who had sufficient PK data for all 4 randomized injection sites to derive PK parameters of interest
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 32 mg CAM2038 Weekly-Buttock | Tss,Max (Time to Maximum Concentration at Steady State) for Each Injection Site | 72.0 h |
| 32 mg CAM2038 Weekly-Abdomen | Tss,Max (Time to Maximum Concentration at Steady State) for Each Injection Site | 72.0 h |
| 32 mg CAM2038 Weekly-Thigh | Tss,Max (Time to Maximum Concentration at Steady State) for Each Injection Site | 72.0 h |
| 32 mg CAM2038 Weekly-Upper Arm | Tss,Max (Time to Maximum Concentration at Steady State) for Each Injection Site | 30.0 h |
Secondary
Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038
Number of Participants with Adverse Events for Both weekly and monthly CAM2038-Safety Population
Time frame: 99 days for Group 1, 162 days for Group 2, 127 days for Group 3
Population: Safety Population: included all subjects who received CAM2038
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with severe grade injection site AEs | 0 participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with moderate grade AEs | 11 participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with Serious TEAEs | 0 participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with TEAEs | 14 participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with severe grade AEs | 0 participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subject with moderate grade non-injection site AEs | 10 participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with moderate grade injection site AEs | 3 participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with at least 1 injection site TEAE | 3 participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with AEs that resulted in death | 0 participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with mild grade injection site AEs | 0 participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with TEAEs that led to drug withdrawn | 0 participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subject with mild grade non-injection site AEs | 3 participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with at least 1 AE | 14 participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with severe grade non-injection site AEs | 0 participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with at least 1 non-injection site AE | 13 participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with mild grade AEs | 3 participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with suspected to be drug-related TEAEs | 4 participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with moderate grade injection site AEs | 1 participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with TEAEs | 10 participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with Serious TEAEs | 0 participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with suspected to be drug-related TEAEs | 3 participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with AEs that resulted in death | 0 participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with at least 1 AE | 10 participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with mild grade AEs | 4 participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with moderate grade AEs | 5 participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with severe grade AEs | 1 participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with at least 1 injection site TEAE | 1 participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with mild grade injection site AEs | 0 participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with severe grade injection site AEs | 0 participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with at least 1 non-injection site AE | 10 participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subject with mild grade non-injection site AEs | 4 participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subject with moderate grade non-injection site AEs | 5 participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with severe grade non-injection site AEs | 1 participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with TEAEs that led to drug withdrawn | 0 participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with Serious TEAEs | 0 participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with severe grade injection site AEs | 0 participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with at least 1 AE | 9 participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with TEAEs that led to drug withdrawn | 0 participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with at least 1 non-injection site AE | 9 participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with AEs that resulted in death | 0 participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with severe grade non-injection site AEs | 0 participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subject with mild grade non-injection site AEs | 4 participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with suspected to be drug-related TEAEs | 2 participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with TEAEs | 9 participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with at least 1 injection site TEAE | 0 participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subject with moderate grade non-injection site AEs | 5 participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with mild grade injection site AEs | 0 participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with severe grade AEs | 0 participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with moderate grade AEs | 5 participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with moderate grade injection site AEs | 0 participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 | Subjects with mild grade AEs | 4 participants |
Other Pre-specified
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Number of Participants with confirmed Opiate Independence as confirmed by Negative Urine Toxicology Tests-ITT Population
Time frame: 99 days for Group 1, 162 days for Group 2, 127 days for Group 3
Population: ITT Population: included all subjects who received at least one dose of CAM2038 and provided some efficacy measures-Note that some patients dropped from the study so the numbers at the baseline may be different from later visits.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 38 | 11 Participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 30 | 9 Participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 31 | 11 Participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 92 | 6 Participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 32 | 12 Participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 33 | 10 Participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 34 | 10 Participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 36 | 11 Participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 50 | 8 Participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 37 | 10 Participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 48 | 9 Participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 47 | 9 Participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 46 | 9 Participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 45 | 9 Participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 44 | 9 Participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 8 | 13 Participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 1 | 13 Participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 43 | 10 Participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 41 | 9 Participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 15 | 11 Participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Baseline | 16 Participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 40 | 10 Participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 22 | 12 Participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 71 | 7 Participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 39 | 10 Participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 23 | 14 Participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 24 | 14 Participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 25 | 13 Participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 26 | 13 Participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 27 | 15 Participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 29 | 12 Participants |
| 32 mg CAM2038 Weekly-Buttock | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 2 | 14 Participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 86 | 9 Participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Baseline | 12 Participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 1 | 11 Participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 2 | 12 Participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 8 | 12 Participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 15 | 10 Participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 22 | 9 Participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 29 | 9 Participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 31 | 8 Participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 36 | 9 Participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 43 | 10 Participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 50 | 8 Participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 57 | 10 Participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 59 | 9 Participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 64 | 10 Participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 71 | 9 Participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 78 | 9 Participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 85 | 10 Participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 155 | 7 Participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 87 | 9 Participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 88 | 9 Participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 89 | 9 Participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 90 | 8 Participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 92 | 9 Participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 95 | 8 Participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 99 | 10 Participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 106 | 8 Participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 113 | 11 Participants |
| 32 mg CAM2038 Weekly-Abdomen | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 134 | 5 Participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 92 | 9 Participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 93 | 9 Participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 64 | 12 Participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 66 | 12 Participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 1 | 13 Participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 94 | 9 Participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 71 | 10 Participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 106 | 9 Participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 78 | 12 Participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 95 | 9 Participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 85 | 13 Participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 96 | 9 Participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 97 | 10 Participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 120 | 12 Participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 99 | 9 Participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 36 | 13 Participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 29 | 10 Participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 38 | 11 Participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 22 | 9 Participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 15 | 12 Participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 9 | 14 Participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 8 | 11 Participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 102 | 7 Participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 43 | 14 Participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 7 | 15 Participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 6 | 15 Participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 5 | 13 Participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 4 | 13 Participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 3 | 15 Participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 2 | 15 Participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Baseline | 14 Participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 50 | 8 Participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 113 | 8 Participants |
| 32 mg CAM2038 Weekly-Thigh | Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests | Day 57 | 13 Participants |
Other Pre-specified
Subject-rated Worst Daily Pain
Subject-rated worst daily pain, using an 11-point numerical rating scale (NRS) for pain, following repeated subcutaneous administration of CAM2038 weekly and CAM2038 monthly in adult opioid-dependent subjects-Safety Population. 11 point scale ranging from 0-10, with 0 being the least amount of pain to 10 being the worst pain imaginable.
Time frame: 99 days for Group 1, 162 days for Group 2, 127 days for Group 3
Population: Safety Population: included all subjects who received CAM2038. Participants did not always enter pain scores in electronic diaries. Also, participants early terminated during the study and stopped entering scores.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 32 mg CAM2038 Weekly-Buttock | Subject-rated Worst Daily Pain | Week 4 | 4.6 score on a scale | Standard Deviation 2.23 |
| 32 mg CAM2038 Weekly-Buttock | Subject-rated Worst Daily Pain | Week 14 | 6.4 score on a scale | Standard Deviation 3.76 |
| 32 mg CAM2038 Weekly-Buttock | Subject-rated Worst Daily Pain | Week 11 | 5.2 score on a scale | Standard Deviation 1.39 |
| 32 mg CAM2038 Weekly-Buttock | Subject-rated Worst Daily Pain | Week 5 | 4.8 score on a scale | Standard Deviation 2.28 |
| 32 mg CAM2038 Weekly-Buttock | Subject-rated Worst Daily Pain | Week 2 | 5.4 score on a scale | Standard Deviation 2.27 |
| 32 mg CAM2038 Weekly-Buttock | Subject-rated Worst Daily Pain | Week 10 | 4.9 score on a scale | Standard Deviation 1.69 |
| 32 mg CAM2038 Weekly-Buttock | Subject-rated Worst Daily Pain | Week 6 | 4.7 score on a scale | Standard Deviation 2.04 |
| 32 mg CAM2038 Weekly-Buttock | Subject-rated Worst Daily Pain | Baseline | 7.6 score on a scale | Standard Deviation 0.33 |
| 32 mg CAM2038 Weekly-Buttock | Subject-rated Worst Daily Pain | Week 9 | 5.3 score on a scale | Standard Deviation 1.55 |
| 32 mg CAM2038 Weekly-Buttock | Subject-rated Worst Daily Pain | Week 7 | 4.3 score on a scale | Standard Deviation 2.11 |
| 32 mg CAM2038 Weekly-Buttock | Subject-rated Worst Daily Pain | Week 13 | 5.1 score on a scale | Standard Deviation 1.58 |
| 32 mg CAM2038 Weekly-Buttock | Subject-rated Worst Daily Pain | Week 8 | 5.2 score on a scale | Standard Deviation 1.53 |
| 32 mg CAM2038 Weekly-Buttock | Subject-rated Worst Daily Pain | Week 3 | 5.3 score on a scale | Standard Deviation 2.25 |
| 32 mg CAM2038 Weekly-Buttock | Subject-rated Worst Daily Pain | Week 1 | 5.8 score on a scale | Standard Deviation 2.4 |
| 32 mg CAM2038 Weekly-Buttock | Subject-rated Worst Daily Pain | Week 12 | 5.2 score on a scale | Standard Deviation 1.53 |
| 32 mg CAM2038 Weekly-Abdomen | Subject-rated Worst Daily Pain | Week 20 | 6.3 score on a scale | Standard Deviation 1.16 |
| 32 mg CAM2038 Weekly-Abdomen | Subject-rated Worst Daily Pain | Week 1 | 4.9 score on a scale | Standard Deviation 2.79 |
| 32 mg CAM2038 Weekly-Abdomen | Subject-rated Worst Daily Pain | Week 21 | 6.1 score on a scale | Standard Deviation 1.61 |
| 32 mg CAM2038 Weekly-Abdomen | Subject-rated Worst Daily Pain | Week 22 | 5.8 score on a scale | Standard Deviation 1.98 |
| 32 mg CAM2038 Weekly-Abdomen | Subject-rated Worst Daily Pain | Week 23 | 8.0 score on a scale | — |
| 32 mg CAM2038 Weekly-Abdomen | Subject-rated Worst Daily Pain | Baseline | 8.3 score on a scale | Standard Deviation 1.3 |
| 32 mg CAM2038 Weekly-Abdomen | Subject-rated Worst Daily Pain | Week 2 | 5.2 score on a scale | Standard Deviation 2.49 |
| 32 mg CAM2038 Weekly-Abdomen | Subject-rated Worst Daily Pain | Week 3 | 5.3 score on a scale | Standard Deviation 2.77 |
| 32 mg CAM2038 Weekly-Abdomen | Subject-rated Worst Daily Pain | Week 4 | 5.5 score on a scale | Standard Deviation 2.92 |
| 32 mg CAM2038 Weekly-Abdomen | Subject-rated Worst Daily Pain | Week 5 | 4.2 score on a scale | Standard Deviation 2.08 |
| 32 mg CAM2038 Weekly-Abdomen | Subject-rated Worst Daily Pain | Week 6 | 4.6 score on a scale | Standard Deviation 2.7 |
| 32 mg CAM2038 Weekly-Abdomen | Subject-rated Worst Daily Pain | Week 7 | 4.9 score on a scale | Standard Deviation 2.44 |
| 32 mg CAM2038 Weekly-Abdomen | Subject-rated Worst Daily Pain | Week 8 | 5.5 score on a scale | Standard Deviation 2.52 |
| 32 mg CAM2038 Weekly-Abdomen | Subject-rated Worst Daily Pain | Week 9 | 5.2 score on a scale | Standard Deviation 2.73 |
| 32 mg CAM2038 Weekly-Abdomen | Subject-rated Worst Daily Pain | Week 10 | 4.8 score on a scale | Standard Deviation 2.6 |
| 32 mg CAM2038 Weekly-Abdomen | Subject-rated Worst Daily Pain | Week 11 | 4.5 score on a scale | Standard Deviation 2.62 |
| 32 mg CAM2038 Weekly-Abdomen | Subject-rated Worst Daily Pain | Week 12 | 5.2 score on a scale | Standard Deviation 2.3 |
| 32 mg CAM2038 Weekly-Abdomen | Subject-rated Worst Daily Pain | Week 13 | 4.4 score on a scale | Standard Deviation 2.7 |
| 32 mg CAM2038 Weekly-Abdomen | Subject-rated Worst Daily Pain | Week 14 | 4.6 score on a scale | Standard Deviation 2.37 |
| 32 mg CAM2038 Weekly-Abdomen | Subject-rated Worst Daily Pain | Week 15 | 4.5 score on a scale | Standard Deviation 2.54 |
| 32 mg CAM2038 Weekly-Abdomen | Subject-rated Worst Daily Pain | Week 16 | 5.5 score on a scale | Standard Deviation 2.37 |
| 32 mg CAM2038 Weekly-Abdomen | Subject-rated Worst Daily Pain | Week 17 | 5.9 score on a scale | Standard Deviation 1.76 |
| 32 mg CAM2038 Weekly-Abdomen | Subject-rated Worst Daily Pain | Week 18 | 5.7 score on a scale | Standard Deviation 2.13 |
| 32 mg CAM2038 Weekly-Abdomen | Subject-rated Worst Daily Pain | Week 19 | 5.8 score on a scale | Standard Deviation 2.03 |
| 32 mg CAM2038 Weekly-Thigh | Subject-rated Worst Daily Pain | Week 3 | 5.4 score on a scale | Standard Deviation 2.05 |
| 32 mg CAM2038 Weekly-Thigh | Subject-rated Worst Daily Pain | Week 15 | 5.5 score on a scale | Standard Deviation 2.08 |
| 32 mg CAM2038 Weekly-Thigh | Subject-rated Worst Daily Pain | Week 12 | 5.9 score on a scale | Standard Deviation 2.34 |
| 32 mg CAM2038 Weekly-Thigh | Subject-rated Worst Daily Pain | Week 2 | 5.4 score on a scale | Standard Deviation 1.85 |
| 32 mg CAM2038 Weekly-Thigh | Subject-rated Worst Daily Pain | Week 17 | 4.3 score on a scale | Standard Deviation 0.76 |
| 32 mg CAM2038 Weekly-Thigh | Subject-rated Worst Daily Pain | Week 13 | 4.4 score on a scale | Standard Deviation 2.14 |
| 32 mg CAM2038 Weekly-Thigh | Subject-rated Worst Daily Pain | Week 7 | 5.8 score on a scale | Standard Deviation 2.32 |
| 32 mg CAM2038 Weekly-Thigh | Subject-rated Worst Daily Pain | Week 1 | 5.6 score on a scale | Standard Deviation 2.1 |
| 32 mg CAM2038 Weekly-Thigh | Subject-rated Worst Daily Pain | Week 8 | 6.1 score on a scale | Standard Deviation 2.08 |
| 32 mg CAM2038 Weekly-Thigh | Subject-rated Worst Daily Pain | Week 6 | 5.2 score on a scale | Standard Deviation 1.98 |
| 32 mg CAM2038 Weekly-Thigh | Subject-rated Worst Daily Pain | Week 16 | 5.8 score on a scale | Standard Deviation 2.24 |
| 32 mg CAM2038 Weekly-Thigh | Subject-rated Worst Daily Pain | Week 9 | 4.9 score on a scale | Standard Deviation 2.19 |
| 32 mg CAM2038 Weekly-Thigh | Subject-rated Worst Daily Pain | Week 5 | 5.3 score on a scale | Standard Deviation 1.88 |
| 32 mg CAM2038 Weekly-Thigh | Subject-rated Worst Daily Pain | Week 14 | 5.1 score on a scale | Standard Deviation 1.96 |
| 32 mg CAM2038 Weekly-Thigh | Subject-rated Worst Daily Pain | Week 10 | 5.2 score on a scale | Standard Deviation 2.02 |
| 32 mg CAM2038 Weekly-Thigh | Subject-rated Worst Daily Pain | Week 4 | 5.6 score on a scale | Standard Deviation 2.31 |
| 32 mg CAM2038 Weekly-Thigh | Subject-rated Worst Daily Pain | Baseline | 6.1 score on a scale | Standard Deviation 2.07 |
| 32 mg CAM2038 Weekly-Thigh | Subject-rated Worst Daily Pain | Week 11 | 5.3 score on a scale | Standard Deviation 2.32 |
Other Pre-specified
Summary of Average Daily Pain by Week (ITT Population)
Summary of Average Daily Pain, using an 11-point Numerical Rating Scale (NRS) for pain, following repeated subcutaneous administration of CAM2038 weekly and CAM2038 monthly in adult opioid-dependent subjects. 11 point scale ranging from 0-10, with 0 being the least amount of pain to 10 being the worst pain imaginable. (ITT Population)
Time frame: 99 days for Group 1, 162 days for Group 2, 127 days for Group 3
Population: ITT Population-consisted of all subjects who received at least 1 injection of CAM2038 and provided some efficacy measures. Participants did not always enter pain scores in electronic diaries. Also, participants early terminated during the study and stopped entering scores.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 32 mg CAM2038 Weekly-Buttock | Summary of Average Daily Pain by Week (ITT Population) | Week 11 | 3.9 score on a scale | Standard Deviation 1.66 |
| 32 mg CAM2038 Weekly-Buttock | Summary of Average Daily Pain by Week (ITT Population) | Week 5 | 3.3 score on a scale | Standard Deviation 2 |
| 32 mg CAM2038 Weekly-Buttock | Summary of Average Daily Pain by Week (ITT Population) | Week 10 | 3.3 score on a scale | Standard Deviation 1.5 |
| 32 mg CAM2038 Weekly-Buttock | Summary of Average Daily Pain by Week (ITT Population) | Week 6 | 3.2 score on a scale | Standard Deviation 1.88 |
| 32 mg CAM2038 Weekly-Buttock | Summary of Average Daily Pain by Week (ITT Population) | Week 2 | 4.0 score on a scale | Standard Deviation 2.19 |
| 32 mg CAM2038 Weekly-Buttock | Summary of Average Daily Pain by Week (ITT Population) | Week 9 | 3.7 score on a scale | Standard Deviation 1.88 |
| 32 mg CAM2038 Weekly-Buttock | Summary of Average Daily Pain by Week (ITT Population) | Week 7 | 3.0 score on a scale | Standard Deviation 2.01 |
| 32 mg CAM2038 Weekly-Buttock | Summary of Average Daily Pain by Week (ITT Population) | Week 1 | 4.4 score on a scale | Standard Deviation 2.37 |
| 32 mg CAM2038 Weekly-Buttock | Summary of Average Daily Pain by Week (ITT Population) | Week 8 | 3.5 score on a scale | Standard Deviation 1.47 |
| 32 mg CAM2038 Weekly-Buttock | Summary of Average Daily Pain by Week (ITT Population) | Week 13 | 3.9 score on a scale | Standard Deviation 1.63 |
| 32 mg CAM2038 Weekly-Buttock | Summary of Average Daily Pain by Week (ITT Population) | Week 3 | 3.9 score on a scale | Standard Deviation 2.18 |
| 32 mg CAM2038 Weekly-Buttock | Summary of Average Daily Pain by Week (ITT Population) | Baseline | 5.7 score on a scale | Standard Deviation 1.06 |
| 32 mg CAM2038 Weekly-Buttock | Summary of Average Daily Pain by Week (ITT Population) | Week 12 | 3.6 score on a scale | Standard Deviation 1.51 |
| 32 mg CAM2038 Weekly-Buttock | Summary of Average Daily Pain by Week (ITT Population) | Week 4 | 3.2 score on a scale | Standard Deviation 2.08 |
| 32 mg CAM2038 Weekly-Buttock | Summary of Average Daily Pain by Week (ITT Population) | Week 14 | 6.0 score on a scale | Standard Deviation 3.42 |
| 32 mg CAM2038 Weekly-Abdomen | Summary of Average Daily Pain by Week (ITT Population) | Week 23 | 6.0 score on a scale | — |
| 32 mg CAM2038 Weekly-Abdomen | Summary of Average Daily Pain by Week (ITT Population) | Baseline | 6.7 score on a scale | Standard Deviation 2.28 |
| 32 mg CAM2038 Weekly-Abdomen | Summary of Average Daily Pain by Week (ITT Population) | Week 5 | 3.0 score on a scale | Standard Deviation 1.99 |
| 32 mg CAM2038 Weekly-Abdomen | Summary of Average Daily Pain by Week (ITT Population) | Week 1 | 3.4 score on a scale | Standard Deviation 2.25 |
| 32 mg CAM2038 Weekly-Abdomen | Summary of Average Daily Pain by Week (ITT Population) | Week 2 | 3.7 score on a scale | Standard Deviation 2.44 |
| 32 mg CAM2038 Weekly-Abdomen | Summary of Average Daily Pain by Week (ITT Population) | Week 3 | 4.0 score on a scale | Standard Deviation 2.59 |
| 32 mg CAM2038 Weekly-Abdomen | Summary of Average Daily Pain by Week (ITT Population) | Week 4 | 3.9 score on a scale | Standard Deviation 2.71 |
| 32 mg CAM2038 Weekly-Abdomen | Summary of Average Daily Pain by Week (ITT Population) | Week 6 | 3.2 score on a scale | Standard Deviation 2.39 |
| 32 mg CAM2038 Weekly-Abdomen | Summary of Average Daily Pain by Week (ITT Population) | Week 7 | 3.7 score on a scale | Standard Deviation 2.2 |
| 32 mg CAM2038 Weekly-Abdomen | Summary of Average Daily Pain by Week (ITT Population) | Week 8 | 3.9 score on a scale | Standard Deviation 2 |
| 32 mg CAM2038 Weekly-Abdomen | Summary of Average Daily Pain by Week (ITT Population) | Week 9 | 3.5 score on a scale | Standard Deviation 2.27 |
| 32 mg CAM2038 Weekly-Abdomen | Summary of Average Daily Pain by Week (ITT Population) | Week 10 | 3.3 score on a scale | Standard Deviation 1.94 |
| 32 mg CAM2038 Weekly-Abdomen | Summary of Average Daily Pain by Week (ITT Population) | Week 11 | 3.0 score on a scale | Standard Deviation 2.1 |
| 32 mg CAM2038 Weekly-Abdomen | Summary of Average Daily Pain by Week (ITT Population) | Week 12 | 3.6 score on a scale | Standard Deviation 1.98 |
| 32 mg CAM2038 Weekly-Abdomen | Summary of Average Daily Pain by Week (ITT Population) | Week 13 | 2.8 score on a scale | Standard Deviation 2.23 |
| 32 mg CAM2038 Weekly-Abdomen | Summary of Average Daily Pain by Week (ITT Population) | Week 14 | 3.2 score on a scale | Standard Deviation 1.98 |
| 32 mg CAM2038 Weekly-Abdomen | Summary of Average Daily Pain by Week (ITT Population) | Week 15 | 3.2 score on a scale | Standard Deviation 2.16 |
| 32 mg CAM2038 Weekly-Abdomen | Summary of Average Daily Pain by Week (ITT Population) | Week 16 | 3.9 score on a scale | Standard Deviation 2.3 |
| 32 mg CAM2038 Weekly-Abdomen | Summary of Average Daily Pain by Week (ITT Population) | Week 17 | 4.1 score on a scale | Standard Deviation 1.92 |
| 32 mg CAM2038 Weekly-Abdomen | Summary of Average Daily Pain by Week (ITT Population) | Week 18 | 3.9 score on a scale | Standard Deviation 2.46 |
| 32 mg CAM2038 Weekly-Abdomen | Summary of Average Daily Pain by Week (ITT Population) | Week 19 | 4.2 score on a scale | Standard Deviation 2.22 |
| 32 mg CAM2038 Weekly-Abdomen | Summary of Average Daily Pain by Week (ITT Population) | Week 20 | 4.4 score on a scale | Standard Deviation 1.93 |
| 32 mg CAM2038 Weekly-Abdomen | Summary of Average Daily Pain by Week (ITT Population) | Week 21 | 4.3 score on a scale | Standard Deviation 2.06 |
| 32 mg CAM2038 Weekly-Abdomen | Summary of Average Daily Pain by Week (ITT Population) | Week 22 | 4.2 score on a scale | Standard Deviation 2.4 |
| 32 mg CAM2038 Weekly-Thigh | Summary of Average Daily Pain by Week (ITT Population) | Week 2 | 4.1 score on a scale | Standard Deviation 1.52 |
| 32 mg CAM2038 Weekly-Thigh | Summary of Average Daily Pain by Week (ITT Population) | Week 17 | 4.3 score on a scale | Standard Deviation 1.44 |
| 32 mg CAM2038 Weekly-Thigh | Summary of Average Daily Pain by Week (ITT Population) | Week 13 | 3.1 score on a scale | Standard Deviation 1.81 |
| 32 mg CAM2038 Weekly-Thigh | Summary of Average Daily Pain by Week (ITT Population) | Week 7 | 4.3 score on a scale | Standard Deviation 1.88 |
| 32 mg CAM2038 Weekly-Thigh | Summary of Average Daily Pain by Week (ITT Population) | Week 1 | 4.5 score on a scale | Standard Deviation 2.12 |
| 32 mg CAM2038 Weekly-Thigh | Summary of Average Daily Pain by Week (ITT Population) | Week 8 | 4.8 score on a scale | Standard Deviation 2.04 |
| 32 mg CAM2038 Weekly-Thigh | Summary of Average Daily Pain by Week (ITT Population) | Week 6 | 3.7 score on a scale | Standard Deviation 1.76 |
| 32 mg CAM2038 Weekly-Thigh | Summary of Average Daily Pain by Week (ITT Population) | Week 16 | 4.5 score on a scale | Standard Deviation 2.15 |
| 32 mg CAM2038 Weekly-Thigh | Summary of Average Daily Pain by Week (ITT Population) | Week 9 | 3.7 score on a scale | Standard Deviation 2.05 |
| 32 mg CAM2038 Weekly-Thigh | Summary of Average Daily Pain by Week (ITT Population) | Week 5 | 4.0 score on a scale | Standard Deviation 1.84 |
| 32 mg CAM2038 Weekly-Thigh | Summary of Average Daily Pain by Week (ITT Population) | Week 14 | 3.8 score on a scale | Standard Deviation 1.8 |
| 32 mg CAM2038 Weekly-Thigh | Summary of Average Daily Pain by Week (ITT Population) | Week 10 | 4.1 score on a scale | Standard Deviation 2.11 |
| 32 mg CAM2038 Weekly-Thigh | Summary of Average Daily Pain by Week (ITT Population) | Week 4 | 4.4 score on a scale | Standard Deviation 2.1 |
| 32 mg CAM2038 Weekly-Thigh | Summary of Average Daily Pain by Week (ITT Population) | Baseline | 5.0 score on a scale | Standard Deviation 2.18 |
| 32 mg CAM2038 Weekly-Thigh | Summary of Average Daily Pain by Week (ITT Population) | Week 11 | 4.1 score on a scale | Standard Deviation 2.23 |
| 32 mg CAM2038 Weekly-Thigh | Summary of Average Daily Pain by Week (ITT Population) | Week 3 | 4.5 score on a scale | Standard Deviation 1.79 |
| 32 mg CAM2038 Weekly-Thigh | Summary of Average Daily Pain by Week (ITT Population) | Week 15 | 4.1 score on a scale | Standard Deviation 1.91 |
| 32 mg CAM2038 Weekly-Thigh | Summary of Average Daily Pain by Week (ITT Population) | Week 12 | 4.4 score on a scale | Standard Deviation 2.23 |