Adjust Font Sizing:

Harmony Biosciences Announces FDA Approval Of WAKIX (pitolisant)

August 16th, 2019

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

# # #
Date Created: August 16th, 2019
Last Updated: August 16th, 2019