FDA Approves Mixed Oxybates for Idiopathic Hypersomnia

The Food and Drug Administration (FDA) has approved mixed salts (calcium, magnesium, potassium, sodium) oxybate (Xywav; Jazz Pharmaceuticals, Dublin, Ireland) for treatment of idiopathic hypersomnia in adults. This is the first treatment approved for idiopathic hypersomnia. 

Approval was based on a results from a phase 3 double-blind, placebo controlled, randomized trial (NCT03533114) that demonstrated the efficacy and safety of mixed salts oxybate for the treatment of idiopathic hypersomnia. Statistically significant and clinically meaningful differences compared with placebo were seen on the Epworth Sleepiness Scale score (P<.001) and the secondary endpoints of Patient Global Impression of Change (P<.001) and the Idiopathic Hypersomnia Severity Scale (P<.001). 

“The clinical program for Xywav has demonstrated that this lower-sodium oxybate is an effective therapy for the treatment of idiopathic hypersomnia,” said Yves Dauvilliers, MD, director, Sleep Disorders Centre, Gui de Chauliac Hospital. “Having an FDA-approved treatment option that manages symptoms associated with idiopathic insomnia, including excessive daytime sleepiness and severe sleep inertia, is a significant step forward for patients. Xywav fulfills an unmet need for those diagnosed with this sleep disorder, offering them management of their debilitating symptoms.” 

The most common adverse reactions in adults (>5%) were nausea, headache, dizziness, anxiety, insomnia, decreased appetite, hyperhidrosis, vomiting, diarrhea, dry mouth, parasomnia, somnolence, fatigue, and tremor.