Axsome NDA Filed for Migraine Therapy

FDA has accepted for review an Axsome Therapeutics NDA for AXS-07 (meloxicam-rizatriptan) for the acute treatment of migraine. The submission 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. The agency has set a user fee review action target date of 4/30/2022.

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 and has been used for many years in treating migraines.