Axsome Therapeutics announces FOCUS Phase 3 trial achieved primary endpoint

Axsome Therapeutics (AXSM) announced that the FOCUS Phase 3 trial of solriamfetol in the treatment of attention deficit hyperactivity disorder achieved its primary and key secondary endpoints demonstrating statistically significant improvements in ADHD symptoms and disease severity with solriamfetol compared to placebo. The FOCUS study was a randomized, double-blind, placebo-controlled, multicenter, U.S. trial, in which 516 adults with ADHD were randomized to receive solriamfetol 150 mg, solriamfetol 300 mg, or placebo, once daily, for 6 weeks. The study achieved the primary endpoint by demonstrating a statistically significant reduction in the Adult ADHD Investigator Symptom Rating Scale total score compared to placebo at Week 6, with mean reductions from baseline of 17.7 points for solriamfetol 150 mg and 14.3 points for placebo. Overall, the improvement with solriamfetol at Week 6 represents a 45% mean reduction from baseline in ADHD symptoms. Improvements in the AISRS total score were greater with solriamfetol compared to placebo starting at Week 1. Clinical response, defined as greater than or equal to30% improvement from baseline in the AISRS total score, was achieved by a statistically significantly greater percentage of patients treated with solriamfetol 150 mg compared to those treated with placebo at Week 6.