Clinical TrialJul 7, 2026, 07:02 AM
Axsome Therapeutics Initiates Phase 3 FOCUS-2 Trial for Solriamfetol in Pediatric ADHD
AI Summary
Axsome Therapeutics announced the dosing of the first patient in its FOCUS-2 Phase 3 trial, evaluating solriamfetol for treating attention deficit hyperactivity disorder (ADHD) in children aged 6 to less than 12 years. This randomized, double-blind, placebo-controlled trial will enroll approximately 468 patients over 6 weeks, with the primary endpoint being the change in ADHD-RS-5 total score. This new trial complements the previously initiated FOCUS-3 Phase 3 trial for adolescents with ADHD, expanding the potential market for solriamfetol, which is a DNRI, TAAR1 agonist, and 5-HT1A agonist.
Key Highlights
- First patient dosed in FOCUS-2 Phase 3 trial for solriamfetol in children with ADHD.
- FOCUS-2 trial evaluates solriamfetol in children aged 6 to less than 12 years with ADHD.
- Approximately 468 patients will be randomized in a 1:1:1 ratio to solriamfetol or placebo for 6 weeks.
- Primary endpoint is change from baseline to week 6 in ADHD Rating Scale (ADHD-RS-5) total score.
- Trial complements the previously announced FOCUS-3 Phase 3 trial for adolescents with ADHD.
- Solriamfetol is a dopamine and norepinephrine reuptake inhibitor (DNRI), TAAR1 agonist, and 5-HT1A agonist.
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