Harmony Biosciences, LLC (Harmony) announced that the 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 DEA.

WAKIX ^®, a first-in-class medication, is a selective histamine 3 (H₃) receptor antagonist/inverse agonist that works through a novel mechanism of action to increase the synthesis and release of histamine, a wake-promoting neurotransmitter in the brain. WAKIX ^® is administered orally once daily in the morning upon wakening.

WAKIX ^® will be commercially available to healthcare professionals and appropriate patients in the US in the fourth quarter of 2019.

To read more about this new medication, go here.