Posted by Michael Wonder on 15 Aug 2019
Harmony Biosciences announces FDA approval of Wakix (pitolisant), a first-in-class medication for the treatment of excessive daytime sleepiness in adult patients with narcolepsy
15 August 2019 - Wakix represents the first and only non-scheduled treatment approved for patients with narcolepsy in the U.S.
Harmony Biosciences announced today that the U.S. FDA approved Wakix (pitolisant) for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy. Wakix is the first and only treatment approved for patients with narcolepsy that is not scheduled as a controlled substance by the U.S. Drug Enforcement Administration.
The efficacy of WAKIX for the treatment of EDS in adult patients with narcolepsy was evaluated in two multicenter, randomized, double-blind, placebo-controlled studies (HARMONY 1 and HARMONY 1bis).
