FOCUS-2 (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 children aged 6 to less than 12 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.

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.