On Aug. 12, 2021, Jazz Pharmaceuticals announced the FDA approved a new indication for Xywav for idiopathic hypersomnia (IH) in adults.
About Xywav
Xywav, also known as JZP258, is a lower-sodium oxybate treatment taken at night to help treat multiple symptoms of IH, including excessive daytime sleepiness, sleep inertia, long sleep time and cognitive impairment. According to Jazz Pharmaceuticals, Xywav can be administered as a twice- or once-nightly regimen for the treatment of IH in adults.
The FDA approval is based on the global Phase 3 double-blind placebo-controlled randomized-withdrawal study that demonstrated the efficacy and safety of Xywav for the treatment of IH in adults. In the study, patients who were randomized to switch from Xywav to placebo experienced worsening on measures of sleepiness and symptoms of IH compared to patients randomized to continue treatment with Xywav.
According to a news release from the FDA, the drug is subject to strict safety controls on prescribing and dispensing; it can be prescribed only by a certified prescriber and dispensed only to an enrolled patient by a certified pharmacy. Only a certified pharmacy that ships directly to patients can dispense Xywav. It will not be available in retail pharmacies.
Xywav oral solution is already approved for the treatment of cataplexy or excessive daytime sleepiness in patients seven years or older with narcolepsy.
This is the first FDA-approved medicine indicated to treat IH.
About idiopathic hypersomnia
IH is a rare sleep disorder characterized by excessive daytime sleepiness despite normal nighttime sleep duration and quality. Individuals with IH may experience difficulty waking up, exhibit confusion or a “sleep drunkenness” state upon awakening, and may find their prolonged daytime naps to be unrefreshing, posing potential risks in activities requiring alertness, such as driving or operating machinery.
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