Axsome Therapeutics Announces FDA Acceptance of NDA Resubmission for AXS-07 for the Treatment of Acute Migraine

NEW YORK, Sept. 4, 2024 (GLOBE NEWSWIRE) — Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the treatment of central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has confirmed the Company’s resubmission of its New Drug Application (NDA) for AXS-07 for the acute treatment of migraine. The FDA has determined the resubmission to be a Class 2 resubmission and has set a target date for action under the Prescription Drug User Fee Act (PDUFA) of January 31, 2025.

About migraine

Migraine is a serious neurological disorder characterized by recurrent attacks of throbbing, often severe and disabling headache, accompanied by nausea, sensitivity to light and sensitivity to sound.¹ An estimated 39 million Americans suffer from migraines. According to the American Migraine Foundation, it is the most common cause of disability among neurological disorders in the United States.²^,3 Published studies of migraine sufferers have shown that more than 70% are not fully satisfied with their current treatment and want therapies that work faster, more effectively, and are less likely to cause symptoms to return.⁴^,⁵

About AXS-07

AXS-07 is a novel, oral, rapidly absorbed, multi-mechanistic investigational drug for the acute treatment of migraine, consisting of meloxicam MoSEIC and rizatriptan. Meloxicam is a novel migraine molecule that was developed using Axsome’s Molecular Solubility Enhanced Inclusion Complex (MoSEIC) technology, which provides rapid absorption of meloxicam while maintaining a long plasma half-life. Meloxicam is a COX-2 preferential nonsteroidal anti-inflammatory drug, and rizatriptan is a 5-HT1B/1D receptor agonist. AXS-07 was developed to provide rapid, enhanced, and sustained relief from migraine, with reduced symptom recurrence. AXS-07 is covered by over 200 issued U.S. and international patents that provide protection until at least 2038. AXS-07 has not been approved by the FDA.

About Axsome Therapeutics

Axsome Therapeutics, Inc. is a biopharmaceutical company that develops and delivers novel therapies for disorders of the central nervous system (CNS) that have limited treatment options. By developing therapeutic options with novel mechanisms of action, we are transforming the approach to treating CNS disorders. At Axsome, we are committed to developing products that significantly improve the lives of patients and provide new treatment options for physicians. For more information, visit the company’s website at www.axsome.com.

Forecast statements

Certain matters discussed in this press release are “forward-looking statements.” In some cases, the Company may use terms such as “anticipates,” “believes,” “potential,” “continues,” “estimates,” “predicts,” “expects,” “plans,” “intends,” “may,” “could,” “will,” “should” or other words that convey the uncertainty of future events or results to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. Forward-looking statements involve risks and uncertainties, including, but not limited to, the continued commercial success of the Company’s Sunosi® and Auvelity® products and the success of the Company’s efforts to obtain any additional indications for solriamfetol and/or AXS-05; the Company’s ability to maintain and expand payer coverage; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund the Company’s disclosed clinical trials, which assumes no material change in the Company’s currently projected revenues or expenses), futility analyses and receipt of interim results that are not necessarily indicative of the final results of the Company’s ongoing clinical trials and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a New Drug Application (“NDA”) for any of the Company’s current product candidates; the Company’s ability to fund additional clinical trials to continue development of the Company’s product candidates; the timing and ability of the Company to obtain and maintain approval by the U.S. Food and Drug Administration (“FDA”) or other regulatory authority or to take other actions with respect to the Company’s product candidates, including statements regarding the timing of filing any NDA application; whether the matters identified by the FDA in the complete response letter could impact the potential approval of the Company’s NDA for AXS-07 for the acute treatment of migraine in adults with or without aura, consistent with the special protocol evaluation of the Company for the MOMENTUM clinical trial; the Company’s ability to successfully defend its intellectual property or obtain necessary licenses at a price acceptable to the Company, if at all; the successful execution of the Company’s research and development and collaboration programs; the success of the Company’s licensing agreements; market acceptance of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required to continue the commercialization of Sunosi and Auvelity and to commercialize the Company’s other product candidates, if approved, and the potential impact on the Company’s anticipated cash resources; the Company’s ability to convert sales into recognized revenues and maintain a favorable ratio of gross to net sales; unforeseen circumstances or other disruptions in normal business operations resulting from or related to the national political climate, geopolitical conflicts or the global pandemic and other factors, including general economic conditions and regulatory changes, beyond the Company’s control. The factors discussed herein could cause actual results and developments to differ materially from those expressed or implied by such statements. Forward-looking statements are made only as of the date of this press release, and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

Investors:
Mark Jacobson
Operations Director
(212) 332-3243
[email protected]

Media:
Darren Opland
Corporate Communications Director
(929) 837-1065
[email protected]

References

Headache Classification Committee of the International Headache Society (IHS) International Headache Classification, 3rd edition. Cephalalgia. 2018;38:1-211.
American Migraine Foundation. 2023.
Steiner TJ et al. Migraine remains the second cause of disability worldwide and the first among young women: results from GBD2019. J Headache Pain. 2020 Dec 2;21(1):137.
Smelt AF, Louter MA, et al. What outcomes do patients consider most important in migraine treatment efficacy trials? Results of the Delphi study. PLoS One. 2014 Jun 16;9(6):e98933.
Lipton RB, Stewart WF. Acute migraine therapy: do physicians understand what migraine patients expect from therapy? Headache. 1999;39(suppl 2):S20-S26.