Sunosi (Solriamfetol) - (FOCUS-3)

July 7, 2026: Axsome Therapeutics, Inc. (NASDAQ: AXSM) announced the first patient has been dosed in FOCUS-2, a Phase 3 randomized, double-blind, placebo-controlled, multicenter trial evaluating solriamfetol for attention deficit hyperactivity disorder (ADHD) in children aged 6 to <12 years. Approximately 468 patients will be randomized 1:1:1 to two solriamfetol doses 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 study will assess efficacy and safety.

The company also noted it previously announced initiation of FOCUS-3, a Phase 3 trial of solriamfetol in adolescents aged 12 to <18 years with ADHD.

Solriamfetol is described as a dopamine and norepinephrine reuptake inhibitor (DNRI), TAAR1 agonist, and 5-HT1A agonist, also being developed for other indications including major depressive disorder with excessive daytime sleepiness, binge eating disorder, and excessive sleepiness associated with shift work disorder.