Axsome Therapeutics has dosed the first patient in its FOCUS-3 Phase 3 trial evaluating solriamfetol as a treatment for adolescents with attention deficit hyperactivity disorder. The randomized, double-blind, placebo-controlled, multicenter study will enroll approximately 468 patients aged 12 to less than 18 years, randomized equally to one of two doses of solriamfetol or placebo for six weeks. The primary endpoint is the change from baseline to week 6 in the ADHD Rating Scale total score. Solriamfetol is a dopamine and norepinephrine reuptake inhibitor also being developed for major depressive disorder with excessive daytime sleepiness, binge eating disorder, and shift work disorder.
Axsome Therapeutics IncDosing first patient in Phase 3 trial for solriamfetol in adolescent ADHD, advancing pipeline.