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FDA has granted its first approval for an idiopathic hypersomnia treatment.
FDA has approved Jazz Pharmaceutical’s Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution, for the treatment of idiopathic hypersomnia (IH) in adults. Xywav was previously approved for the treatment of cataplexy or excessive daytime sleepiness in patients seven years or older with narcolepsy. This is the first approval FDA has granted to IH, an uncommon sleep disorder that causes one to become excessively sleepy throughout the day even after a good night’s sleep.
A double-blind randomized-withdrawal study consisting of 154 adults aged 19–75 was done where applicants were randomized to switch from Xywav to a placebo. It found that those switched to a placebo experienced worsening of measures related to sleepiness and symptoms of IH compared to those who stayed on Xywav.
The drug’s active moiety is oxybate, also known as gamma-hydroxybutyrate (GHB), which is a Schedule I controlled substance. Known side effects include seizures, trouble breathing, changes in alertness, coma, and death. Because it is a Schedule I controlled substance, it falls under strict safety protocols. It can only be prescribed by a certified prescriber, and dispensed only to an enrolled patient by a certified pharmacy. It will not be available in retail pharmacies.
FDA granted Xywav Fast Track and Priority Review designations. It was also given an Orphan Drug Designation, which provides additional incentives for treatments intended for rare conditions.
“A novel indication for Xywav is significant as the FDA has never granted an approval for idiopathic hypersomnia,” said Eric Bastings, deputy director of the Office of Neuroscience in FDA’s Center for Drug Evaluation and Research. “Idiopathic hypersomnia is a life-long condition, and the approval of Xywav will be instrumental in providing treatment for symptoms such as excessive sleepiness and difficulty waking, and in effectively managing this debilitating disorder.”