Sunosi (Solriamfetol) - (FOCUS-3)

June 26, 2026: Axsome Therapeutics, Inc. (NASDAQ: AXSM) announced dosing of the first patient in FOCUS-3, a Phase 3 randomized, double-blind, placebo-controlled, multicenter trial evaluating solriamfetol for adolescents (ages 12 to <18) with attention deficit hyperactivity disorder (ADHD). The study plans to enroll approximately 468 patients, randomized 1:1:1 to two solriamfetol dose arms or placebo for 6 weeks. The primary endpoint is change from baseline to week 6 in ADHD Rating Scale (ADHD-RS-5) total score. The release notes solriamfetol’s mechanism (dopamine and norepinephrine reuptake inhibitor, TAAR1 agonist, and 5-HT1A agonist) and states it is also being developed for ADHD, major depressive disorder with excessive daytime sleepiness, binge eating disorder, and excessive sleepiness associated with shift work disorder. No timeline for results or regulatory filing was provided.