Axsome Launches Phase 3 Solriamfetol Trial for Binge Eating Disorder

Axsome Therapeutics, a biopharmaceutical firm, has launched the ENGAGE Phase 3 clinical trial for solriamfetol, a potential treatment for adults with binge eating disorder (BED). The study, which began screening participants in March 2024, is a randomized, double-blind, placebo-controlled, multicenter trial. It aims to evaluate the efficacy and safety of solriamfetol, with approximately 450 adults expected to participate. The trial will compare the effects of two dosages of solriamfetol (150 or 300 mg) against a placebo over a 12-week period, with the primary focus being the reduction in binge eating episodes.

BED is a prevalent eating disorder, characterized by episodes of consuming large quantities of food in a short time while feeling a lack of control. It is associated with distress and is notably more common among women. The disorder affects an estimated 2.8% of U.S. adults, equating to around 7 million people.

Solriamfetol, the drug under investigation, is a compound that inhibits the reuptake of dopamine and norepinephrine and stimulates the trace amine-associated receptor 1 (TAAR1). It is not yet approved by the FDA for the treatment of BED.

Axsome Therapeutics is dedicated to developing innovative treatments for central nervous system conditions that currently have limited options. The company focuses on creating therapeutics with unique mechanisms of action to improve the treatment landscape for CNS disorders. Their commitment is to develop products that can significantly enhance the quality of life for patients and offer new options for healthcare providers.