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This hypersomnia treatment just received an extended approval for cataplexy and excessive daytime sleepiness.
The US Food and Drug Administration (FDA) has expanded the approval for Jazz Pharmaceuticals’ Xywav to include treatment of idiopathic hypersomnia in adults. Xywav, a lower-sodium oxybate, was cleared by the FDA last year to treat cataplexy or excessive daytime sleepiness in patients aged 7 years or older with narcolepsy.
According to the CEO of Jazz Pharmaceuticals, Bruce Cozadd, Xywav is "the first and only medicine indicated to treat idiopathic hypersomnia."1
This decision is based on a randomized phase III study that showed Xywav led to "statistically significant and clinically meaningful differences" compared to placebo on the primary endpoint of Epworth Sleepiness Scale (ESS) score. At study entry, the mean ESS score was 15.7, and by the end of the stable-dose period, mean ESS score was 6.1. In the secondary goal, measured by the Idiopathic Hypersomnia Severity Scale (IHSS), the mean IHSS score was 31.6 at study entry and 15.3 at the end of the stable-dose period.
"We have been working for nearly a decade to develop Xywav, a unique oxybate product with a significant reduction in sodium. We are proud to advance the science behind our sleep research program in order to continue making a difference for people living with narcolepsy," Cozadd said following the first approval of Xywav.2
1. Bratulic A. FDA okays broader use for Jazz's sleep disorder drug Xywav. News release. August 12, 2021. Accessed August 16, 2021. https://new.firstwordpharma.com/story/5373711
2. Jazz Pharmaceuticals. Jazz Pharmaceuticals announces US FDA approval of Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for cataplexy or excessive daytime sleepiness associated with narcolepsy. News release. July 22, 2020. Accessed August 16, 2021. https://new.firstwordpharma.com/story/5066099