Axsome Doses First Patient in Phase 3 FOCUS-3 Trial of Solriamfetol for Adolescent ADHD

Axsome Therapeutics has dosed the first patient in the Phase 3 FOCUS-3 (Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol) trial evaluating solriamfetol for adolescents with attention deficit hyperactivity disorder (ADHD). The study marks an important milestone in the drug’s late-stage clinical development and advances a potential new treatment option for adolescents living with ADHD.

Mechanism of Action

Solriamfetol is an investigational dopamine and norepinephrine reuptake inhibitor (DNRI) that also exhibits trace amine-associated receptor 1 (TAAR1) agonist and 5-HT1A receptor agonist activity. By modulating multiple neurotransmitter pathways involved in attention, arousal, and executive function, the investigational therapy is being evaluated across several central nervous system disorders.

Beyond ADHD, solriamfetol is also under clinical development for major depressive disorder with excessive daytime sleepiness (EDS), binge eating disorder (BED), and excessive sleepiness associated with shift work disorder (SWD).

Disease Background

ADHD is a chronic neurodevelopmental disorder characterized by persistent inattention, hyperactivity, and impulsivity that interfere with academic performance, social functioning, and daily life. Many patients also experience impairments in executive function, working memory, planning, and behavioral inhibition.

An estimated 7 million children and 15.5 million adults in the United States are affected by ADHD, with symptoms persisting into adulthood in more than two-thirds of affected children. ADHD contributes to an estimated $120 billion annual economic burden among U.S. adults, highlighting the need for additional effective treatment options.

Phase 3 Trial Design

The Phase 3 FOCUS-3 study is a randomized, double-blind, placebo-controlled, multicenter trial enrolling 468 adolescents with ADHD aged 12 to less than 18 years.

Participants will be randomized in a 1:1:1 ratio to receive 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-5 (ADHD-RS-5) total score, a validated measure of ADHD symptom severity. The trial will also evaluate the overall safety and tolerability of the investigational therapy in the adolescent population.

Clinical Development

FOCUS-3 is the first Phase 3 study evaluating solriamfetol in adolescents with ADHD and expands the company’s broader clinical development program in neuropsychiatric disorders. The study evaluates whether the investigational DNRI can produce clinically meaningful improvements in core ADHD symptoms while maintaining an acceptable safety profile over six weeks.

Data from the trial will further define the efficacy and safety profile of solriamfetol in adolescent patients and support its potential as a novel DNRI-based treatment option for ADHD.

Development Plans

Positive Phase 3 results could support future regulatory submissions for solriamfetol in adolescent ADHD while further expanding its clinical development across multiple central nervous system disorders. In addition to ADHD, the company continues to evaluate the therapy in major depressive disorder with excessive daytime sleepiness, binge eating disorder, and excessive sleepiness associated with shift work disorder.

Reference

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