Axsome Therapeutics, Inc. has just announced the initiation of the ENGAGE phase 3 trial of Solriamfetol, an investigational treatment for Binge Eating Disorder (BED) in adults. This trial is a significant development in the company's efforts to address the management of Central Nervous System (CNS) disorders.
The ENGAGE trial is a randomized, double-blind, placebo-controlled, multicenter trial that will involve approximately 450 patients. The patients will be randomized in a 1:1:1 ratio to receive either Solriamfetol at 150mg or 300mg, or a placebo for a period of 12 weeks. The primary endpoint of the trial will be to assess the change in binge eating episodes.
Binge Eating Disorder (BED) is a prevalent and serious condition, affecting an estimated 2.8% of U.S. adults, approximately 7 million people. It is also notably more common in women, being 1.75 times more prevalent in females.
Solriamfetol, the investigational treatment being evaluated, is described as a dopamine and norepinephrine reuptake inhibitor and trace amine-associated receptor 1 (TAAR1) agonist. It's important to note that Solriamfetol is not yet approved by the FDA for the treatment of BED.
Axsome Therapeutics, Inc. is a biopharmaceutical company dedicated to developing and delivering novel therapies for CNS conditions that currently have limited treatment options. This commitment is exemplified through the initiation of the ENGAGE trial, as the company aims to transform the approach to treating CNS conditions and provide new therapeutic options for both patients and physicians.
Following these announcements, the company's shares moved -2.8%, and are now trading at a price of $77.54. For more information, read the company's full 8-K submission here.
