Axsome Therapeutics Announces FDA Acceptance of NDA Resubmission for AXS-07 for the Acute Treatment of Migraine

Core Viewpoint - Axsome Therapeutics has resubmitted its New Drug Application (NDA) for AXS-07 for the acute treatment of migraine, with the FDA setting a PDUFA action goal date of January 31, 2025 [1] Industry Overview - Migraine affects approximately 39 million Americans and is the leading cause of disability among neurological disorders in the U.S. [2] - Over 70% of migraine sufferers express dissatisfaction with current treatments, seeking faster and more consistent relief [2] Company Overview - Axsome Therapeutics is focused on developing novel therapies for central nervous system (CNS) disorders with limited treatment options [4] - The company aims to transform the treatment of CNS conditions through innovative mechanisms of action [4] Product Overview - AXS-07 is an investigational oral medication combining MoSEIC™ meloxicam and rizatriptan, designed for rapid and consistent migraine relief [3] - AXS-07 utilizes MoSEIC technology for enhanced absorption and has over 200 patents protecting its formulation until at least 2038 [3]