Axsome Launches 468-Patient Phase 3 Solriamfetol Trial in ADHD Teens
AXSM•Axsome Therapeutics has dosed the first patient in its FOCUS-3 Phase 3 trial evaluating solriamfetol in 468 adolescents (12-17) with ADHD. The randomized, double-blind, placebo-controlled study will assess two solriamfetol doses against placebo over six weeks, measuring change in ADHD-RS-5 total score from baseline to week 6.
1. FOCUS-3 Phase 3 Trial Launch
Axsome Therapeutics has initiated dosing in its FOCUS-3 Phase 3 trial of solriamfetol for adolescents with ADHD, marking the first patient enrolled in the study. This milestone follows completion of earlier-phase trials in adults and expands the drug’s evaluation into a younger population aged 12 to less than 18 years.
2. Study Design and Endpoints
The multicenter trial will randomize approximately 468 participants in a 1:1:1 ratio to receive one of two solriamfetol doses or placebo for six weeks. The primary efficacy measure is the change from baseline to week 6 in the ADHD Rating Scale (ADHD-RS-5) total score, with safety and tolerability also closely monitored.
3. Market Opportunity and Solriamfetol Profile
ADHD affects an estimated 7 million children in the U.S., creating a significant market opportunity if solriamfetol demonstrates efficacy and safety in adolescents. Solriamfetol’s dual dopamine-norepinephrine reuptake inhibition and TAAR1 agonism differentiate it from current stimulant therapies, potentially addressing unmet needs in cognitive function and behavioral control.
