Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia

An Open-Label Study to Assess the Long-Term Safety and Efficacy of AXS-14 in the Management of Fibromyalgia

Status

Enrolling by invitation

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07637162

Enrollment

300

Registered

2026-06-09

Start date

2026-04-29

Completion date

2028-05-01

Last updated

2026-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Keywords

Fibromyalgia, Central Sensitization, Allodynia, Hyperalgesia, Hypersensitivity to sensory stimuli, Inhibitor of the norepinephrine transporter (NET), Esreboxetine, AXS-14, Axsome, Norepinephrine reuptake inhibitor

Brief summary

This is a Phase 3, multi-center, 52-week, open-label trial to evaluate the long-term safety and efficacy of AXS-14 in the management of fibromyalgia.

Detailed description

Eligible subjects will have previously participated in the AXS-14-FM-301 (FORWARD) study. Subjects in this open-label extension trial will receive open-label AXS-14 for up to 52 weeks.

Interventions

DRUGAXS-14 (esreboxetine)

AXS-14 tablets taken twice daily.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Participation in AXS-14-FM-301.

Exclusion criteria

* Unable to comply with study procedures. * Medically inappropriate for study participation in the opinion of the Investigator.

Design outcomes

Primary

Measure	Time frame	Description
Long-term Safety	Up to 52 weeks.	Incidence of treatment-emergent adverse events following dosing with AXS-14

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 5, 2026