Harmony Biosciences announced on Oct. 13, 2020, that the U.S. Food and Drug Administration has approved Wakix (pitolisant) for the treatment of cataplexy in adult patients with narcolepsy. The FDA previously approved Wakix for the treatment of excessive daytime sleepiness in adult patients with narcolepsy.
According to Harmony, Wakix is a selective histamine 3 (H₃) receptor antagonist/inverse agonist. It 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 after waking up in the morning. It has been commercially available in the U.S. since 2019.
Harmony reports that Wakix is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S. Drug Enforcement Administration. The most common adverse reactions to Wakix, occurring in 5 percent of adults or more, were insomnia, nausea, and anxiety.
Narcolepsy is a sleep disorder that causes daily periods of excessive daytime sleepiness. Other symptoms can include cataplexy, which is a sudden loss in muscle tone triggered by strong emotion.
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Photo: U.S. Food and Drug Administration.