October 14, 2020

The U.S. FDA has approved an expanded indication for Wakix® (pitolisant), manufactured by Harmony Biosciences. The drug is now indicated to treat cataplexy and excessive daytime sleepiness (EDS) in adults who have narcolepsy. Previously, it was approved only for the treatment of EDS in adults diagnosed with narcolepsy.

Up to two thirds of adults who have narcolepsy also experience cataplexy, a sudden loss of muscle tone that leads to weakness or paralysis. Ordinarily, this loss of muscle tone should occur as a natural part of rapid eye movement (REM) sleep. However, because narcolepsy interferes with the body’s ability to regulate the sleep-wake cycle, the loss of muscle tone happens when the individual is fully awake and aware. The effects range from mild, such as drooping eyelids, to severe, including total physical collapse. Often, cataplexy is triggered by strong emotions, including excitement and laughter. Episodes can last for up to two minutes. In some instances, the individual will fall asleep immediately after.

In clinical trials, Wakix demonstrated statistically significant reductions in the rate of cataplexy compared to placebo. Dosage should be initiated at 8.9mg once daily for the first week, then increased to a maintenance dose of 17.8mg once daily in the second week. If needed, the dose can be titrated up to a maximum recommended dosage of 35.6mg once daily. Dosage adjustments are required for patients who have hepatic or renal impairment, or who are poor CYP2D6 metabolizers (which can be determined using a pharmacogenetic test).

Wakix first received FDA approval in 2019.

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