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Axsome Therapeutics Gets FDA CRL For AXS-07 NDA For Acute Treatment Of Migraine

Biopharmaceutical company Axsome Therapeutics, Inc. (AXSM) announced Monday that the Company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for AXS-07 for the acute treatment of migraine.

The CRL did not identify or raise any concerns about the clinical efficacy or safety data in the NDA, and the FDA did not request any new clinical trials to support the approval of AXS-07.

However, the principal reasons given in the CRL relate to chemistry, manufacturing, and controls (CMC) considerations. The CRL identified the need for additional CMC data pertaining to the drug product and manufacturing process.

Axsome believes that the issues raised in the CRL are addressable and intends to provide potential timing for a resubmission following consultation with the FDA.

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.

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