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# Axsome NDA for Cataplexy in Patients with Narcolepsy
- URL: https://www.fdaweb.com/axsome-nda-for-cataplexy-in-patients-with-narcolepsy/
- Published: 2026-07-15T12:00:00.000Z
- Updated: 2026-09-14T13:43:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161464

FDA has accepted for review an Axsome Therapeutics NDA for AXS-12 (reboxetine) for the treatment of cataplexy in patients with narcolepsy. The agency has set a review action target date of 5/1/2027.

If approved, AXS-12 would become a new treatment option for cataplexy, a hallmark symptom of narcolepsy characterized by sudden episodes of muscle weakness triggered by strong emotions. The investigational therapy is a highly selective norepinephrine reuptake inhibitor that is designed to address multiple symptoms of narcolepsy, including cataplexy, excessive daytime sleepiness and cognitive impairment, according to the company.

The NDA is based on data from the Phase 3 SYMPHONY clinical trial, along with findings from the Phase 3 ACCORD trial and the Phase 2 CONCERT trial. According to Axsome, the studies demonstrated statistically significant reductions in weekly cataplexy attacks compared with placebo while also showing improvements in excessive daytime sleepiness and measures of cognition. The company reported that AXS-12 was generally well tolerated across the clinical program.