RTTNews | Sep 14, 2021 07:53AM EDT

07:53 Tuesday, September 14, 2021 (RTTNews.com) - Biopharmaceutical company Axsome Therapeutics, Inc. (AXSM) announced Tuesday that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for AXS-07 for the acute treatment of migraine. It has set a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2022 for the NDA.

AXS-07 is a novel, oral, rapidly absorbed, multi-mechanistic investigational medicine for the acute treatment of migraine, consisting of MoSEIC meloxicam and rizatriptan.

The NDA is supported by results from two Phase 3 randomized, double-blind, controlled trials of AXS-07 in the acute treatment of migraine, the MOMENTUM and INTERCEPT trials, which demonstrated statistically significant elimination of migraine pain with AXS-07 compared to placebo and active controls.

Read the original article on RTTNews ( https://www.rttnews.com/3225504/axsome-therapeutics-says-fda-accepts-axs-07-nda-for-acute-treatment-of-migraine-quick-facts.aspx)

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