Axsome Therapeutics Says FDA Accepts AXS-07 NDA For Acute Treatment Of Migraine - Quick Facts

(RTTNews) - 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.