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# Axsome Therapeutics Gets FDA Inspection Confirmation
- URL: https://www.fdaweb.com/axsome-therapeutics-gets-fda-inspection-confirmation/
- Published: 2022-02-09T12:00:00.000Z
- Updated: 2026-09-14T17:32:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151121

FDA has told Axsome Therapeutics that it will now meet its inspection deadline on inspecting the company’s contract manufacturing facility related to a 9/2021-submitted NDA for AXS-07 (meloxicam-rizatriptan) for the acute treatment of migraine. Previously, the agency had notified Axsome that due to Covid-19 pandemic-related travel restrictions the inspection could be delayed, which could impact a review decision before the user fee review action target date of 4/30\. The agency restarted domestic inspections 2/7 in response to declining Covid cases across the country.

The NDA is supported by data from two Phase 3 randomized, double-blind, controlled trials, MOMENTUM and INTERCEPT, which the company says demonstrated statistically significant elimination of migraine pain compared to placebo and active controls. Axsome describes AXS-07 as an oral, rapidly absorbed, multi-mechanistic drug comprising meloxicam and rizatriptan. Meloxicam is a COX-2 preferential non-steroidal anti-inflammatory drug that is enabled by Axsome’s Molecular Solubility Enhanced Inclusion Complex technology to allow rapid absorption while maintaining a long plasma half-life, the company says. Rizatriptan belongs to the triptan drug class that has been used for many years in treating migraines.