FDA Accepts Axsome's NDA Resubmission for AXS-07 for Acute Migraine Treatment

Axsome Therapeutics, Inc. (NASDAQ: AXSM) announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of their New Drug Application (NDA) for AXS-07, a novel treatment for acute migraine. The FDA classified the resubmission as Class 2 and established a Prescription Drug User Fee Act (PDUFA) action goal date of January 31, 2025. 

Migraine is a significant neurological disorder marked by recurrent, often severe and disabling headaches, frequently accompanied by nausea and sensitivity to light and sound. In the United States, around 39 million people suffer from migraines, making it the leading cause of disability among neurological conditions, as reported by the American Migraine Foundation. Surveys reveal that over 70% of migraine sufferers are dissatisfied with their current treatments, seeking faster, more consistent relief with fewer symptom recurrences. 

AXS-07 is an innovative, oral medication designed for rapid and consistent migraine relief. It combines MoSEIC™ meloxicam and rizatriptan. Meloxicam, enhanced by Axsome’s proprietary MoSEIC technology, allows for quick absorption while maintaining a prolonged half-life. It functions as a COX-2 preferential non-steroidal anti-inflammatory drug. Rizatriptan, on the other hand, is a 5-HT1B/1D receptor agonist. Together, these compounds aim to provide quick and sustained relief from migraine symptoms while minimizing recurrence. AXS-07 is safeguarded by over 200 issued patents in the U.S. and internationally, ensuring protection until at least 2038. Currently, AXS-07 has not received FDA approval.

Axsome Therapeutics is a biopharmaceutical company dedicated to developing and delivering novel therapies for central nervous system (CNS) disorders, particularly those with limited treatment options. The company's mission is to transform the treatment landscape for CNS conditions by providing innovative therapeutic solutions. Axsome is committed to improving patient outcomes through the development of products with unique mechanisms of action, thereby offering new therapeutic options for healthcare providers. 

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