Axsome Therapeutics has kicked off a key late-stage push in its CNS pipeline.

 

The pharma powerhouse has announced that the first patient has been dosed in the FOCUS-3 Phase 3 trial of solriamfetol in adolescents with attention deficit hyperactivity disorder (ADHD).

 

The company said FOCUS-3 (Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study designed to evaluate both the efficacy and safety of solriamfetol in adolescents aged 12 to less than 18 years with ADHD.

 

The trial will enroll approximately 468 patients, who will be randomized in a 1:1:1 ratio to receive one of two doses of solriamfetol or placebo over a 6-week treatment period. The study’s primary endpoint will measure the change from baseline to week 6 in the ADHD Rating Scale (ADHD-RS-5) total score.