Jazz Pharma's Xywav Gets FDA Approval for Idiopathic Hypersomnia in Adults

August 25, 20210

Jazz Pharmaceuticals announced the USFDA approval of Xywav as the first and the only medicine indicated to treat idiopathic hypersomnia. Xywav is a calcium, magnesium, potassium and sodium oxybates oral solution for the treatment of idiopathic hypersomnia in adults. Idiopathic Hypersomnia (IH) is a lifelong condition of neurologic sleep disorder characterized by chronic excessive daytime sleepiness and Jazz pharmaceuticals indicated that about 37,000 people in the U.S. have been diagnosed with IH. TT

Xywav can be administered as a twice or once-nightly regimen for the treatment of idiopathic hypersomnia in adults. Xywav received USFDA fast track designation approval in September 2020 and Priority Review designation as part of the supplemental New Drug Application (sNDA) acceptance in April 2021. This FDA approval is based on a global Phase 3 study in patients aged between 19 to 75 years. The most common side effects of the drug were nausea, headache and dizziness. Due to potential of Xywav being misused as it has warning as a central nervous system (CNS) depressant, it is currently not available in retail pharmacies and can only be available through a restricted program called the Xywav and Xyrem REMS.  

The Xywav and Xyrem REMS is developed in consultation with the USFDA and designed to ensure that Xywav and Xyrem are provided to patients securely and that patients are educated on the appropriate use of the medicines, understand the risks and safe use conditions of these medicines, and agree to follow the requirements of the Xywav and Xyrem REMS. Both prescribers and patients must enroll in the program. Additionally, a Nurse Case Management program is available for people taking Xyrem and Xywav to help address questions about their treatment  

Xywav was already approved in July 2020 for the treatment of excessive daytime sleepiness and sudden loss of muscle tone (cataplexy) in patients aged seven years and older with narcolepsy and this marks the second FDA approval for this oral drug. Narcolepsy is a chronic sleep disorder and is associated with an increased prevalence of certain comorbid conditions, including hypertension and cardiovascular disease.  

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