By Colin Kellaher

Axsome Therapeutics Inc. on Thursday said it plans to resubmit its application for AXS-07 for the acute treatment of migraine to the U.S. Food and Drug Administration in the third quarter of 2023.

Axsome said the decision follows a meeting with the FDA to discuss the New York company's plan to address issues the agency raised earlier this year when it rejected the initial application.

Axsome said it would include new chemistry, manufacturing and controls information, including stability data on newly manufactured commercial-scale batches of AXS-07, in its resubmission package, adding that the FDA didn't request any additional clinical efficacy or safety trials.

Axsome said it expects the FDA to designate the resubmission as "Class 2," which would subject it to a six-month review.

Axsome last month won long-awaited FDA approval of Auvelity, a fast-acting treatment for major depressive disorder in adults.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

September 29, 2022 08:01 ET (12:01 GMT)

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