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AXS-07 FDA Approval Status

Last updated by Judith Stewart, BPharm on Sep 16, 2021.

FDA Approved: No
Brand name: AXS-07
Generic name: meloxicam and rizatriptan
Company: Axsome Therapeutics, Inc.
Treatment for: Migraine

AXS-07 (meloxicam and rizatriptan) is a non-steroidal anti-inflammatory drug and triptan combination in development for the acute treatment of migraine.

  • Meloxicam is a selective COX-2 inhibitor non-steroidal anti-inflammatory drug used in the treatment of arthritis. Meloxicam is a new molecular entity for the treatment of migraine enabled by Axsome’s MoSEIC (Molecular Solubility Enhanced Inclusion Complex) technology, which results in rapid absorption of the drug while maintaining a long plasma half-life. Rizatriptan is a 5-HT1B/1D agonist approved for the acute treatment of migraine.
  • AXS-07 is designed to be a rapidly absorbed, multi-mechanistic medicine for migraine.
  • 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, and has set a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2022.

Development timeline for AXS-07

DateArticle
May  2, 2022Axsome Therapeutics Receives FDA Complete Response Letter for New Drug Application for AXS-07 for the Acute Treatment of Migraine
Sep 14, 2021Axsome Therapeutics Announces FDA Acceptance of New Drug Application for AXS-07 for the Acute Treatment of Migraine

Further information

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