Axsome Therapeutics has earned a Breakthrough Therapy designation from the FDA for AXS-12 (reboxetine) for the treatment of cataplexy, a sudden loss of voluntary muscle tone, in patients with narcolepsy.

The designation was based on the results of a phase 2 trial in which AXS-12 reduced the number of cataplexy attacks compared to a placebo over a two-week treatment period.

The FDA granted AXS-12 an Orphan Drug designation in 2018 for the treatment of narcolepsy.