Axsome Announces FDA Acceptance of New Drug Application for AXS-12 in Narcolepsy

Axsome Therapeutics announced that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for AXS-12 (reboxetine), a potential treatment for cataplexy in patients with narcolepsy. The acceptance marks a key regulatory milestone for the drug candidate.

Key Details

• Product Candidate: AXS-12 (reboxetine) for the treatment of cataplexy in narcolepsy.
• Regulatory Milestone: The FDA has accepted the NDA and set a Prescription Drug User Fee Act (PDUFA) target action date of May 1, 2027.
• Additional Information: The FDA has indicated that it does not currently plan to hold an advisory committee meeting to discuss the application.