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

In the FOCUS study, 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 (AISRS) 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 (p=0.039).

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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 (p=0.036).

Clinical response, defined as ≥30% improvement from baseline in the AISRS total score, was achieved by a statistically significantly greater percentage of patients treated with solriamfetol 150 mg (53.5%) compared to those treated with placebo (41.3%) at Week 6 (p=0.024).

The study also achieved the key secondary endpoint by statistically significantly reducing overall ADHD disease severity compared to placebo, as assessed by the Clinical Global Impression of Severity (CGI-S) for ADHD, at Week 6 (p=0.017).

Results on the primary and key secondary endpoints for the exploratory 300 mg solriamfetol dose were numerically superior compared to placebo but were not statistically significant.

Solriamfetol was safe and well tolerated in the trial.

Price Action: AXSM stock is down 5.27% at $122.36 at the last check Tuesday.

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