Biopharmaceutical company Axsome Therapeutics, known for developing innovative therapies for central nervous system (CNS) disorders, announced that the FDA (Food and Drug Administration) has accepted their New Drug Application (NDA) for AXS-07 for acute migraine treatment. AXS-07 (MoSEIC™ meloxicam-rizatriptan) is designed as an oral, rapidly absorbent, multi-mechanistic, investigational medicine for migraines. The NDA was based on data from two Phase 3 randomized, double-blind, controlled trial results. Axsome Therapeutics plans for a Prescription Drug User Fee Act (PDUFA) action date of early 2022.
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