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Harmony Biosciences Announces FDA Approval Of WAKIX (pitolisant)

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

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

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