Axsome Therapeutics Announces FDA Pre-NDA Meeting Minutes for AXS-12 in Narcolepsy Supporting NDA Submission

Core Viewpoint - Axsome Therapeutics is on track to submit a New Drug Application (NDA) for AXS-12, a treatment for cataplexy in narcolepsy, by January 2026, following positive feedback from the FDA regarding the regulatory data package [2][3][4]. 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 excessive daytime sleepiness associated with narcolepsy [8]. Product Details - AXS-12 (reboxetine) is a selective norepinephrine reuptake inhibitor and cortical dopamine modulator, aimed at treating narcolepsy by promoting wakefulness and enhancing cognition [7]. - AXS-12 has received Orphan Drug Designation from the FDA, which may provide seven years of marketing exclusivity upon approval and a waiver of application user fees [5]. Clinical Development - The clinical development program for AXS-12 includes three controlled efficacy trials and a completed long-term safety trial, indicating a robust approach to validating the drug's effectiveness and safety [4]. Market Context - Narcolepsy is a serious neurological condition affecting the sleep-wake cycle, characterized by excessive daytime sleepiness and cataplexy, which impacts cognitive and social functioning and is associated with a higher mortality rate [6].