Axsome Therapeutics Announces FDA Acceptance and Priority Review of Supplemental New Drug Application for AXS-05 for the Treatment of Alzheimer’s Disease Agitation

Core Viewpoint - The FDA has granted Axsome Therapeutics' AXS-05 a Priority Review designation for the treatment of Alzheimer's disease agitation, with a target action date set for April 30, 2026, indicating a significant step towards addressing an unmet medical need in this area [1][2][3]. Company Overview - Axsome Therapeutics is a biopharmaceutical company focused on developing treatments for central nervous system (CNS) disorders, with a portfolio that includes FDA-approved therapies for major depressive disorder and other conditions [7][8]. - The company aims to deliver scientific breakthroughs by identifying gaps in care and developing differentiated products that improve patient outcomes [7]. Product Details - AXS-05 is an investigational drug combining dextromethorphan and bupropion, designed to treat agitation in Alzheimer's disease and smoking cessation [6]. - The drug has been granted Breakthrough Therapy designation by the FDA, which is intended to expedite its development and review process due to its potential for significant improvement over existing therapies [3][6]. Clinical Development - The supplemental NDA for AXS-05 is based on a comprehensive clinical development program, including four Phase 3 clinical trials and a long-term safety trial [4]. - Agitation affects up to 76% of Alzheimer's patients, highlighting the critical need for effective treatments in this area [5][3].