Axsome Therapeutics Announces FDA Pre-NDA Meeting Minutes for AXS-05 in Alzheimer’s Disease Agitation Supporting NDA Submission

Core Insights - Axsome Therapeutics is preparing to submit a supplemental New Drug Application (sNDA) for AXS-05, aimed at treating agitation in Alzheimer's disease, with submission anticipated in the third quarter of 2025 [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, narcolepsy, and migraine [6] Product Details - AXS-05 is an investigational drug combining dextromethorphan and bupropion, functioning as an NMDA receptor antagonist and sigma-1 agonist, with a unique formulation designed to enhance bioavailability [5] - The drug has received Breakthrough Therapy designation from the FDA for Alzheimer's disease agitation, indicating its potential to address significant unmet medical needs [2][5] Clinical Development - The clinical development program for AXS-05 includes four completed pivotal Phase 3 trials, demonstrating statistically significant improvements in agitation symptoms compared to placebo [3] - AXS-05 has shown a favorable safety profile, with no deaths reported and no increased risk of falls, sedation, or cognitive decline in long-term studies [3] Market Context - Alzheimer's disease affects approximately 7 million people in the U.S., with agitation reported in up to 70% of patients, highlighting a significant market opportunity for effective treatments [4]