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FDA Approved the Expanded Use Of WAKIX® (pitolisant) for the Treatment of Cataplexy

October 14th, 2020

Harmony Biosciences Holdings, Inc. (“Harmony”) announced that the US Food and Drug Administration (FDA) has approved WAKIX® (pitolisant) for the treatment of cataplexy in adult patients with narcolepsy. WAKIX®, the first and only treatment for excessive daytime sleepiness or cataplexy associated with narcolepsy that is not a controlled substance by the US Drug Enforcement Administration, was previously approved by the FDA to treat excessive daytime sleepiness in adults with narcolepsy in August 2019.

According to Harmony’s website, “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.”

To read the full press release about WAKIX®, go here.

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Date Created: October 14th, 2020
Last Updated: December 21st, 2023