8-K: Axsome Therapeutics' Solriamfetol Achieves Positive Phase 3 Results in ADHD Trial

Axsome Therapeutics announces positive results from its Phase 3 FOCUS trial of solriamfetol in adults with ADHD, demonstrating statistically significant improvements in ADHD symptoms and disease severity compared to placebo.

Summary

• Axsome Therapeutics' FOCUS Phase 3 trial of solriamfetol in adults with ADHD met its primary and key secondary endpoints.
• The trial demonstrated a statistically significant improvement in ADHD symptoms as measured by the AISRS total score compared to placebo (p=0.039, 150 mg solriamfetol).
• A statistically significant reduction in overall ADHD disease severity was observed as measured by the CGI-S score compared to placebo (p=0.017, 150 mg solriamfetol).
• The study involved 516 adults with ADHD who were randomized to receive solriamfetol 150 mg, solriamfetol 300 mg, or placebo once daily for 6 weeks.
• Patients treated with solriamfetol 150 mg showed a 45% mean reduction from baseline in ADHD symptoms.
• Clinical response, defined as a 30% improvement from baseline in the AISRS total score, was achieved by 53.5% of patients treated with solriamfetol 150 mg compared to 41.3% with placebo (p=0.024).
• The onset of action was observed as early as Week 1 compared to placebo (p=0.036, AISRS, 150 mg solriamfetol).
• Solriamfetol was generally well-tolerated, with a safety profile consistent with prior trials.
• Axsome plans to initiate a trial in pediatric patients this year.

Sentiment

Score: 8

Explanation: The document presents positive clinical trial results, suggesting a potential new treatment option for ADHD. The sentiment is optimistic due to the statistically significant improvements and favorable safety profile.

Positives

• Solriamfetol demonstrated statistically significant improvements in ADHD symptoms and disease severity compared to placebo.
• The drug was well-tolerated with a safety profile consistent with prior trials.
• The onset of action was observed as early as Week 1.
• The results support the potential of solriamfetol as a new treatment option for adults with ADHD.
• The company plans to initiate a trial in pediatric patients this year.

Negatives

• 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.

Risks

• The commercial success of Sunosi, Auvelity, and Symbravo products and the success of the Company's efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05 are not guaranteed.
• The company's ability to maintain and expand payer coverage is subject to change.
• The success, timing and cost of the Company's ongoing clinical trials and anticipated clinical trials for the Company's current product candidates are subject to change.
• The company's ability to fund additional clinical trials to continue the advancement of the Company's product candidates is not guaranteed.
• The timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration (FDA) or other regulatory authority approval of, or other action with respect to, the Company's product candidates is not guaranteed.
• The company's ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all is not guaranteed.
• The successful implementation of the Company's research and development programs and collaborations is not guaranteed.
• The success of the Company's license agreements is not guaranteed.
• The acceptance by the market of the Company's products and product candidates, if approved is not guaranteed.
• The Company's anticipated capital requirements, including the amount of capital required for the commercialization of Sunosi, Auvelity, and Symbravo and for the Company's commercial launch of its other product candidates, if approved, and the potential impact on the Company's anticipated cash runway are subject to change.
• The Company's ability to convert sales to recognized revenue and maintain a favorable gross to net sales is not guaranteed.
• Unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company's control are subject to change.

Future Outlook

Axsome plans to advance the development of solriamfetol as a potential new treatment for ADHD and initiate a trial in pediatric patients this year.

Management Comments

• Gregory Mattingly, M.D., stated that the results demonstrate that solriamfetol was able to reduce mean ADHD symptom burden by nearly fifty percent, which contributed to significant reductions in disease severity.
• Herriot Tabuteau, MD, Chief Executive Officer of Axsome, said they are pleased with the positive results of the FOCUS trial and look forward to advancing the development of solriamfetol as a new, differentiated potential treatment for patients living with ADHD.

Industry Context

The positive results from the FOCUS trial position Axsome Therapeutics to potentially compete in the ADHD treatment market, which has a significant unmet need, with an estimated 15.5 million adults and 7 million children affected in the U.S.

Comparison to Industry Standards

• The efficacy of solriamfetol in reducing ADHD symptoms, as measured by the AISRS and CGI-S scores, can be compared to existing ADHD medications such as stimulants (e.g., Adderall, Ritalin) and non-stimulants (e.g., Strattera, Intuniv).
• A direct comparison would require a head-to-head trial, but the reported 45% mean reduction from baseline in ADHD symptoms with solriamfetol 150 mg suggests a potentially competitive efficacy profile.
• The safety and tolerability profile of solriamfetol will also be a key factor in its adoption compared to existing treatments, some of which have known side effects such as insomnia, appetite suppression, and cardiovascular risks.

Stakeholder Impact

• Shareholders may react positively to the news of successful trial results.
• Patients with ADHD may benefit from a new treatment option.
• The company's employees may be impacted by the increased workload associated with advancing the development of solriamfetol.

Next Steps

• Axsome plans to advance the development of solriamfetol for ADHD treatment.
• The company intends to initiate a trial in pediatric patients this year.

Key Dates

Keywords

Solriamfetol, ADHD, Axsome Therapeutics, Clinical Trial, FOCUS Trial, CNS Disorders, AISRS, CGI-S, Phase 3 Trial