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Axsome Therapeutics Announces FDA Acceptance of New Drug Application for AXS-12 for the Treatment of Cataplexy in Narcolepsy

AXSM
  • FDA accepted the New Drug Application (NDA) for AXS-12 (reboxetine) for the treatment of cataplexy in narcolepsy.
  • The FDA set a Prescription Drug User Fee Act (PDUFA) target action date of May 1, 2027.
  • The FDA indicated no current plans to hold an advisory committee meeting to discuss the application.
  • AXS-12 is a selective norepinephrine reuptake inhibitor & cortical dopamine modulator under development for narcolepsy.
  • AXS-12 has been granted Orphan Drug Designation by the FDA but is not yet approved.
  • Cataplexy affects an estimated 70% of narcolepsy patients & involves sudden loss of muscle tone triggered by strong emotions.
  • Axsome Therapeutics holds FDA-approved treatments for major depressive disorder, agitation in dementia, excessive daytime sleepiness, & migraine.
  • The press release includes standard forward-looking statements regarding risks, clinical trial timelines, regulatory approvals, & commercialization efforts.