Axsome Therapeutics Initiates FOCUS-3 Phase 3 Trial of Solriamfetol in Adolescents with Attention Deficit Hyperactivity Disorder (ADHD)

About this update from Axsome Therapeutics, Inc.

NEW YORK, June 26, 2026 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that the first patient has been dosed in the FOCUS-3 Phase 3 trial evaluating solriamfetol as a treatment for adolescents with attention deficit hyperactivity disorder (ADHD). FOCUS-3 (Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the efficacy and safety of solriamfetol in adolescents aged 12 to less than 18 years with ADHD. Approximately 468 patients will be randomized in a 1:1:1 ratio to receive one of two doses of solriamfetol or placebo for 6 weeks. The primary endpoint will be the change from baseline to week 6 in the ADHD Rating Scale (ADHD-RS-5) total score. About Attention Deficit Hyperactivity Disorder (ADHD) Attention deficit hyperactivity disorder (ADHD) is a chronic neurobiological and developmental disorder characterized by a persistent pattern of inattention, hyperactivity, or impulsivity, that interferes with functioning or development.1 Impairments in cognition are apparent in attention, planning and problem solving, working memory, and behavioral inhibition.2,3 An estimated 15.5 million adults and 7 million children in the U.S. are affected by ADHD,4,5 with approximately two-thirds or more of children with ADHD continuing to experience symptoms into adulthood.6 The total annual societal excess cost associated with adult ADHD in the U.S. has been estimated at over $120 billion.7 About Solriamfetol Solriamfetol is a dopamine and norepinephrine reuptake inhibitor (DNRI), TAAR1 agonist, and 5-HT1A agonist being developed for the treatment of attention deficit hyperactivity disorder (ADHD), major depressive disorder (MDD) with excessive daytime sleepiness (EDS), binge eating disorder (BED), and excessive sleepiness associated with shift work disorder (SWD). About Axsome Therapeutics Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in ...

View stock analysis, news, and events for Axsome Therapeutics, Inc.