Axsome Therapeutics, Inc. has announced the acceptance of the resubmission of its new drug application (NDA) for AXS-07 by the U.S. Food and Drug Administration (FDA). The FDA has classified the resubmission as a class 2 resubmission and set a Prescription Drug User Fee Act (PDUFA) action goal date of January 31, 2025.
AXS-07 is an oral, rapidly absorbed, multi-mechanistic investigational medicine for the acute treatment of migraine, composed of Moseic™ meloxicam and rizatriptan. It is designed to offer rapid, enhanced, and consistent relief of migraine with reduced symptom recurrence.
The company has highlighted that AXS-07 is covered by more than 200 issued U.S. and international patents, providing protection until at least 2038. It is essential to note that AXS-07 has not yet been approved by the FDA.
Migraine, a serious neurological condition, affects an estimated 39 million Americans and is the leading cause of disability among neurological disorders in the United States. Published surveys of migraine sufferers have revealed that more than 70% are not fully satisfied with their current treatment and desire therapies that work faster, more consistently, and result in less symptom recurrence.
This announcement signifies a significant step forward for Axsome Therapeutics in its efforts to develop and deliver novel therapies for the management of central nervous system (CNS) disorders. The company is dedicated to developing products that meaningfully improve the lives of patients and offer new therapeutic options for physicians. As a result of these announcements, the company's shares have moved 0.9% on the market, and are now trading at a price of $89.65. For more information, read the company's full 8-K submission here.
