13 October 2020 - Wakix is the first and only non-scheduled treatment approved for excessive daytime sleepiness or cataplexy in adult patients with narcolepsy.
Harmony Biosciences today announced the U.S. FDA has approved Wakix (pitolisant) for the treatment of cataplexy in adult patients with narcolepsy. Wakix is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S. Drug Enforcement Administration.
Wakix received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019.