FDA Approves Jazz Pharma’s Xywav for Idiopathic Hyperinsomnia

Jazz Pharmaceuticals’ Xywav (calcium, magnesium, potassium, and sodium oxybates), already approved for narcolepsy, has won a new indication as a treatment for idiopathic hypersomnia (IH) in adults.

People with IH are excessively sleepy during the day even if they get sufficient sleep at night. Xywav is an oral solution of calcium, magnesium, potassium and sodium oxybates previously approved for the treatment of cataplexy or excessive daytime sleepiness in patients seven years or older with narcolepsy.

Xywav is the first drug to be approved for IH, said Eric Bastings, deputy director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research.

The approval was supported by results from a discontinuation study conducted in 154 adults. Those who switched from Xywav to placebo experienced worse sleep scores and increased IH symptoms relative to those who continued treatment.