Axsome Therapeutics Initiates FORWARD Phase 3 Trial of AXS-14 for the Management of Fibromyalgia

January 15, 2026 – Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical – Axsome Therapeutics, central nervous system diseases, clinical trials, fibromyalgia, neuroscience

15 January 2026 — New York, US — Axsome Therapeutics, Inc, a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced the first patient has been dosed in the FORWARD Phase 3 trial of AXS-14 (esreboxetine) for the management of fibromyalgia.

FORWARD (Fibromyalgia Response with Esreboxetine Evaluated Using a Randomized Withdrawal Research Design) is a Phase 3, double-blind, placebo-controlled, multicenter, randomized withdrawal trial in patients with fibromyalgia consisting of an open-label AXS-14 treatment period and a randomized, double-blind treatment period. Patients achieving a treatment response during the 12-week open-label period will be randomized in a 1:1 ratio to continue AXS-14 (8 mg) once daily or to switch to matching placebo for up to 12 weeks or until a loss of therapeutic response occurs. The primary endpoint will be the time from randomization to loss of therapeutic response.

About Axsome Therapeutics
Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com