Phase 3 solriamfetol trial initiated for treatment of binge-eating disorder in adults

Key takeaways:

• Over 12 weeks, 450 adult patients will receive 150 mg or 300 mg of solriamfetol or placebo.
• The efficacy of solriamfetol will be determined by the change in binge-eating episodes.

Axsome Therapeutics has initiated a phase 3 trial of solriamfetol to assess its safety and efficacy for the treatment of binge-eating disorder among adults, according to a company press release.

Solriamfetol (Sunosi, Axsome Therapeutics) is a dopamine and norepinephrine reuptake inhibitor and trace amine-associated receptor 1 (TAAR1) agonist that, as Healio previously reported, has been approved by the FDA for the treatment of excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea.

Researchers of the phase 3, randomized, double-blind, placebo-controlled, multicenter ENGAGE (Elucidating TAAR-1, Dopamine and Norepinephrine in Binge-Eating Disorder Using Solriamfetol) trial will randomly assign 450 patients 1:1:1 to receive 150 mg or 300 mg doses of solriamfetol or placebo for 12 weeks. Change in binge-eating episodes will serve as the study’s primary endpoint. Researchers screened the first patient for the trial in March.

According to the release, binge-eating disorder is the most common eating disorder, affecting approximately 7 million U.S. adults, and it is 1.75 times more common among women.