Axsome Therapeutics' ADHD Trial Achieves Primary, Key Secondary Endpoints

Axsome Therapeutics

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(RTTNews) - Axsome Therapeutics, Inc. (AXSM), Tuesday announced that the FOCUS Phase 3 trial of solriamfetol in the treatment of attention deficit hyperactivity disorder or ADHD achieved its primary and key secondary endpoints.

The randomized, double-blind, placebo-controlled, multicenter, U.S. trial comprised of 516 adults with ADHD. They 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 and 45 percent mean reduction in baseline ADHD symptoms.

Additionally, the study achieved the key secondary endpoint by statistically significantly reducing overall ADHD disease severity compared to placebo.

Moreover, the study also showed the favorable safety and tolerability profile of solriamfetol.

Looking ahead, the company plans to initiate a trial in pediatric patients in 2025.

In the pre-market hours, Axsome's stock is trading at $130, up 0.64 percent on the Nasdaq.