Harmony Biosciences announced Aug. 15, 2019, that the U.S. Food and Drug Administration has approved Wakix (pitolisant) for the treatment of excessive daytime sleepiness in adult patients with narcolepsy. Harmony states that Wakix is the only treatment approved for patients with narcolepsy that is not scheduled as a controlled substance by the U.S. Drug Enforcement Agency.
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. In studies, the most common side effects were insomnia, nausea and anxiety.
According to Harmony, the effectiveness of Wakix was evaluated in two multicenter, randomized, double-blind, placebo-controlled studies of 261 patients. In both, Wakix showed a statistically significant improvement in excessive daytime sleepiness as measured by the Epworth Sleepiness Scale score.
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