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

Conditions

• Fibromyalgia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• AXS-14 (esreboxetine) — DRUG
  AXS-14 tablets taken twice daily.

Study Details

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.

Key Dates

First listed

Jun 9, 2026

Start date

Apr 29, 2026

Status verified

Sep 2026

Primary completion

May 31, 2028

Completion

May 31, 2028

Study Design

Enrollment

300 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: AXS-14 (esreboxetine)
  Up to 52 weeks.

Primary Outcome Measure

Long-term Safety [ Time Frame: Up to 52 weeks. ]

Locations (31)

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