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Axsome Therapeutics Completes Successful FDA Pre-NDA Meeting for AXS-07 for the Acute Treatment of Migraine
NDA submission on track for 4Q 2020 NEW YORK, Aug. 20, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company
About this update from Axsome Therapeutics, Inc.
[{"type":"text","content":" NDA submission on track for 4Q 2020\n NEW YORK, Aug. 20, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that it has completed a successful pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) for AXS-07 for the acute treatment of migraine. AXS-07 is Axsome’s novel, oral, multi-mechanistic investigational medicine for the acute treatment of migraine. The purpose of the meeting was to reach agreement with the FDA on the proposed content and format of the Company’s planned NDA submission including the clinical and nonclinical requirements. Based on the feedback from the FDA, the Company believes its regulatory data package will be sufficient to support an NDA for AXS-07 for the acute treatment of migraine, and Axsome remains on track to submit the planned NDA in the fourth quarter of 2020. Acceptance of the final NDA will be subject to the FDA’s review of the complete filing. “Axsome is pleased with the outcome of our recent pre-NDA meeting with the FDA, which confirmed the studies and data to be presented in our planned NDA submission of AXS-07 for the acute treatment of migraine,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “AXS-07 incorporates multiple mechanisms of action, and rapid absorption after oral administration, to address various migraine processes with the goal of providing enhanced effectiveness. We remain on track to complete the submission in the fourth quarter to make this new potential therapy available to patients living with migraine.” Axsome previously announced positive results from two Phase 3, randomized, controlled trials of AXS-07 in the acute treatment of migraine, the MOMENTUM and INTERCEPT trials, which demonstrated rapid, substantial, and statistically significant elimination of migraine pain and prevention of progression of migraine pain intensity with AXS-07 compared to control. MOMENTUM, conducted pursuant to an FDA Special Protocol Assessment, randomized 1,594 patients with a history of inadequate response to prior acute migraine treatments to treat a single migraine attack with AXS-07, rizatriptan, MoSEIC™ meloxicam, or placebo. Rizatriptan, an active comparator in the trial, is considered to ...