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Axsome Therapeutics Announces FDA Acceptance and Priority Review of Supplemental New Drug Application for AXS-05 for the Treatment of Alzheimer's Disease Agitation

AXSM
  • The FDA accepted Axsome Therapeutics' supplemental New Drug Application for AXS-05 for Alzheimer's disease agitation & granted Priority Review designation.
  • The Prescription Drug User Fee Act (PDUFA) target action date for the application is set for April 30, 2026.
  • Priority Review indicates the FDA aims to complete the review within 6 months rather than the standard 10 months.
  • AXS-05 combines dextromethorphan HBr & bupropion HCl to treat agitation in up to 76% of Alzheimer's patients.
  • The FDA previously granted Breakthrough Therapy designation for AXS-05 in June 2020 for this indication.
  • The supplemental NDA is based on four randomized Phase 3 clinical trials & a long-term safety trial.
  • AXS-05 is currently approved in the U.S. for major depressive disorder but remains unapproved for Alzheimer's disease agitation.
  • Axsome Therapeutics holds a patent estate for AXS-05 extending to at least 2043.