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

Core Viewpoint - Axsome Therapeutics has received positive feedback from the FDA regarding the planned supplemental NDA submission for AXS-05, aimed at treating agitation in Alzheimer's disease, indicating a potential new treatment option for a condition with high unmet medical needs [1][2][3] Company Overview - Axsome Therapeutics is a biopharmaceutical company focused on developing treatments for central nervous system disorders, with a portfolio that includes FDA-approved therapies for various conditions [7] Product Information - AXS-05 is an investigational drug combining dextromethorphan and bupropion, functioning as an NMDA receptor antagonist and sigma-1 agonist, currently under development for Alzheimer's disease agitation and smoking cessation [5] - The drug has been granted Breakthrough Therapy designation by the FDA, which allows for expedited review processes [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 long-term safety and tolerability in over 300 patients treated for at least six months, with no deaths reported and no increased risk of falls or cognitive decline [3] Market Context - Alzheimer's disease affects approximately 7 million people in the U.S., with agitation reported in up to 70% of these patients, highlighting a significant market need for effective treatments [4]