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# CMC Issues Hinder Axsome NDA on Migraine Drug
- URL: https://www.fdaweb.com/cmc-issues-hinder-axsome-nda-on-migraine-drug/
- Published: 2022-04-25T12:00:00.000Z
- Updated: 2026-09-14T17:41:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151669

Axsome Therapeutics says it expects to receive a complete response letter on its NDA for AXS-07 (meloxicam-rizatriptan), indicated for the acute treatment of migraine, after the agency recently told the company that chemistry, manufacturing, and controls issues identified during the NDA’s review remain unresolved. The user fee review action target date is 4/30.

In February, FDA told Axsome that it would meet its inspection deadline on inspecting the company’s contract manufacturing facility for the 9/2021-submitted NDA. 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.

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.