Axsome's Phase 3 Trial of Solriamfetol for ADHD Meets Main Goal

Axsome Therapeutics, Inc., a prominent biopharmaceutical company focused on developing treatments for central nervous system disorders, revealed noteworthy outcomes from its FOCUS Phase 3 trial concerning solriamfetol and its effectiveness in treating ADHD. Conducted as a randomized, double-blind, placebo-controlled study across multiple centers in the U.S., the trial included 516 adult participants diagnosed with ADHD. These participants were randomly assigned to receive either solriamfetol (at doses of 150 mg or 300 mg) or a placebo, administered once daily over a period of six weeks. The trial's primary endpoint was successfully met, showcasing a significant reduction in the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score in comparison to the placebo group by Week 6. Specifically, the solriamfetol 150 mg cohort experienced an average decrease of 17.7 points from baseline, contrasted with a 14.3 point decrease in the placebo group, resulting in a p-value of 0.039. This improvement corresponds to a 45% reduction in ADHD symptoms from baseline levels. Notably, enhancements in the AISRS total score for solriamfetol were observed as early as Week 1, with a p-value of 0.036.

Moreover, the study achieved its key secondary endpoint by significantly reducing overall ADHD disease severity, as measured by the Clinical Global Impression of Severity (CGI-S) for ADHD, when compared to placebo by Week 6, yielding a p-value of 0.017. The exploratory group receiving a 300 mg dose of solriamfetol showed numerically superior results to placebo, albeit not reaching statistical significance.

The trial also highlighted a favorable safety profile for solriamfetol, which was consistent with previous studies. Importantly, no serious adverse events emerged, and the occurrence of side effects was correlated with dosage levels.

Dr. Gregory Mattingly, an Associate Clinical Professor of Psychiatry at Washington University School of Medicine and President of the American Professional Society for ADHD and Related Disorders, emphasized the profound impact ADHD has on various aspects of life, including social, academic, and occupational performance, while also influencing quality of life and elevating risks of morbidity and mortality. He acknowledged the promising results from the FOCUS trial, noting that solriamfetol reduced ADHD symptom burden by almost 50%, which significantly lowered disease severity. Dr. Mattingly pointed out the potential of solriamfetol to be a key component in a comprehensive wellness strategy for individuals diagnosed with ADHD, given the drug's efficacy and favorable tolerability profile.

Axsome's CEO, Herriot Tabuteau, expressed satisfaction with the encouraging findings from the FOCUS trial, marking the first evidence from a multicenter controlled trial demonstrating solriamfetol's efficacy in treating ADHD. Recognizing the heterogeneous and widespread nature of ADHD, Dr. Tabuteau conveyed the company's commitment to advancing solriamfetol's development as a new therapeutic option for adults battling the disorder. With these promising results, Axsome plans to initiate a subsequent trial involving pediatric patients.

In summary, the FOCUS trial not only reinforced the efficacy of solriamfetol in mitigating ADHD symptoms and disease severity among adults but also underscored its potential as a well-tolerated treatment option. With a favorable safety profile and significant symptom improvement demonstrated early in the trial, solriamfetol presents a promising avenue for addressing ADHD in adult populations while paving the way for future studies in younger age groups.