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A Long-Term, Open-Label Phase 3 MOVEMENT Trial of AXS-07 in the Acute Treatment of Migraine

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Trial Profile

A Long-Term, Open-Label Phase 3 MOVEMENT Trial of AXS-07 in the Acute Treatment of Migraine

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Jun 2025

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At a glance

  • Drugs Meloxicam/rizatriptan (Primary)
  • Indications Migraine; Migraine with aura; Migraine without aura
  • Focus Adverse reactions; Registrational
  • Acronyms MOVEMENT
  • Sponsors Axsome Therapeutics

Most Recent Events

  • 18 Jun 2025 According to an Axsome Therapeutics media release, the company will present the data from this study at the 67th Annual Scientific Meeting of the American Headache Society (AHS), being held June 19-22, 2025, in Minneapolis, Minnesota.
  • 30 Jan 2025 According to an Axsome Therapeutics media release, the U.S. Food and Drug Administration (FDA) has approved SYMBRAVO (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults.
  • 04 Sep 2024 According to an Axsome media release, the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of the Company's New Drug Application (NDA) for AXS-07 for the acute treatment of migraine. The FDA designated the resubmission as a Class 2 resubmission and set a Prescription Drug User Fee Act (PDUFA) action goal date of January 31, 2025.

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