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Narcolepsy drug WAKIX

Snippets - A Small piece of News or Article

FDA approves Non-Controlled treatment for Excessive Daytime Sleepiness

The U.S. Food and Drug Administration has approved WAKIX (pitolisant) to treat excessive daytime sleepiness (EDS) in adult patients with narcolepsy. The Narcolepsy therapy, developed by HARMONY therapeutics, is the first and the only treatment to get approval that is not labelled as a controlled substance by the US Drug Enforcement Administration (DEA). Last year in the month of May, Wakix secured both Breakthrough Therapy Designation and Fast Track Designation from the FDA which previously was designated Orphan Drug. Administered orally once in a day, WAKIX is a selective histamine 3 (H₃) receptor antagonist/inverse agonist. The drug works by increasing the synthe...

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