Axsome Therapeutics has dosed the first patient in its FOCUS-2 Phase 3 trial evaluating solriamfetol for children aged 6 to less than 12 years with Attention Deficit Hyperactivity Disorder (ADHD). The trial aims to assess the efficacy and safety of the treatment in this pediatric population, addressing a significant unmet medical need.

FOCUS-2 is a randomized, double-blind, placebo-controlled, multicenter study designed to evaluate two doses of solriamfetol against a placebo. Approximately 468 patients will be randomized in a 1:1:1 ratio to receive one of the two doses or the placebo for a treatment duration of six weeks.

The primary endpoint of the trial is the change from baseline to week 6 in the ADHD Rating Scale (ADHD-RS-5) total score. This measure will help determine the drug's impact on ADHD symptoms in children.

Previously, Axsome announced the initiation of the FOCUS-3 Phase 3 trial of solriamfetol in adolescents aged 12 to less than 18 years with ADHD. The progression of the pediatric clinical program underscores Axsome's commitment to developing treatments across different age groups affected by ADHD.

The trial design and endpoints are structured to provide robust data on the potential benefits and risks of solriamfetol in younger patients. Results from this study will inform future regulatory submissions and potential treatment options for children with ADHD.

Axsome Therapeutics, Inc. has dosed the first patient in the FOCUS-3 Phase 3 trial evaluating solriamfetol as a treatment for adolescents with attention deficit hyperactivity disorder (ADHD). The trial aims to assess the efficacy and safety of the drug in this patient population, addressing a critical gap in care for CNS disorders.

FOCUS-3 (Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial. Approximately 468 patients aged 12 to less than 18 years with ADHD 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 is the change from baseline to week 6 in the ADHD Rating Scale (ADHD-RS-5) total score.

About Solriamfetol

Solriamfetol is a dopamine and norepinephrine reuptake inhibitor (DNRI), TAAR1 agonist, and 5-HT1A agonist. It is being developed for the treatment of ADHD, major depressive disorder (MDD) with excessive daytime sleepiness (EDS), binge eating disorder (BED), and excessive sleepiness associated with shift work disorder (SWD).

Trial Design

About Axsome Therapeutics

Axsome Therapeutics is a biopharmaceutical company focused on the treatment of central nervous system (CNS) conditions. The company's portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as multiple novel product candidates addressing serious neurological and psychiatric conditions.