Axsome Therapeutics Inc.
Axsome Therapeutics Resubmits NDA for Migraine Treatment AXS-07
Summary
On September 4, 2024, Axsome Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of the Company's New Drug Application (NDA) for AXS-07 for the acute treatment of migraine. The FDA has set a Prescription Drug User Fee Act (PDUFA) action goal date of January 31, 2025. AXS-07 is a novel, oral, rapidly absorbed, multi-mechanistic investigational medicine for the acute treatment of migraine, consisting of meloxicam and rizatriptan. The resubmission follows a previous Complete Response Letter (CRL) received from the FDA.
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About Axsome Therapeutics Inc.
Axsome Therapeutics Inc. specializes in the development and commercialization of transformative therapies for central nervous system (CNS) disorders. The company's focus is on addressing unmet medical needs in the fields of depression, migraines, and agitation associated with Alzheimer's disease, among other CNS conditions. Axsome's robust pipeline includes both clinical and preclinical stage compounds, highlighting a commitment to innovation and efficacy. By utilizing novel mechanisms of action, their product candidates aim to offer significant advantages over existing treatments. Axsome Therapeutics plays a crucial role in the pharmaceutical and healthcare sectors, helping reshape treatment paradigms for complex and challenging CNS disorders. Through strategic collaborations and leveraging cutting-edge research methods, the company seeks to provide effective healthcare solutions and improve quality of life for patients globally. Established on a vision to impact lives positively, Axsome continues to advance its clinical programs and regulatory approvals, thereby reinforcing its position in the biotechnology industry.
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