Axsome Therapeutics has reached agreement with the FDA under a special protocol assessment, or SPA, for the design, endpoints and statistical approach of the planned MOMENTUM Phase 3 trial of AXS-07 in the acute treatment of migraine. MOMENTUM will enroll only patients with a history of inadequate response to prior migraine treatments. The SPA provides agreement that the MOMENTUM trial design adequately addresses objectives that, if met, will support the regulatory submission for approval of AXS-07 for the indication of acute treatment of migraine in adults with or without aura. Based on FDA feedback during this SPA process, Axsome believes that only one Phase 3 trial may be needed for the approval of AXS-07. Axsome anticipates starting the MOMENTUM trial in Q1, with topline results expected within approximately one year of trial initiation.
https://thefly.com/landingPageNews.php?id=2859851
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