Wakix Approved to Treat Narcolepsy
August 14, 2019 – The U.S. FDA has approved Wakix® (pitolisant), manufactured by Harmony Biosciences, to treat excessive daytime sleepiness (EDS) in adult patients who have narcolepsy. A first-in-class medication, it is the only FDA-approved treatment for patients with narcolepsy that is not scheduled as a controlled substance by the U.S. Drug Enforcement Administration (DEA).
Approximately 200,000 people in the United States have narcolepsy, a neurologic disorder that affects the sleep-wake cycle. Excessive daytime sleepiness is a universal feature of narcolepsy, and is defined as the inability to stay awake during the day. The majority of cases are tied to the loss of a neuropeptide in the brain needed to create a stable sleep-wake cycle.
A selective histamine 3 (H₃) receptor antagonist/inverse agonist, Wakix increases the production and release of histamine, a wakefulness-promoting neurotransmitter. In clinical studies, the drug produced a statistically significant improvement in EDS as measured by the Epworth Sleepiness Scale (ESS) score. Recommended dosing 8.9mg once daily for the first week, then 17.8mg once daily for the second week. If needed, the dose can be titrated up after the second week to a maximum of 35.6mg per day. Wakix should be taken upon waking. Dosage adjustments are required for patients with hepatic or renal impairment, and for individuals who are poor CYP2D6 metabolizers. It should not be used by patients who have severe liver disease.
Harmony Biosciences plans to launch the product during the fourth quarter of 2019. Pricing has not yet been announced.