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Ideopathic hupersomnia hypnogram8/14/2023 With this launch we will have achieved our goal of five product launches in two years." 1 "This milestone exemplifies our patient-focused R&D strategy and internal development capabilities, and underscores oxybate as a key growth opportunity for Jazz. "We are excited that with today's approval Xywav will become the first and only medicine indicated to treat idiopathic hypersomnia, a unique medical condition that can have significant effects on the lives of those diagnosed with the condition," Bruce Cozadd, chairman and chief executive officer, Jazz Pharmaceuticals, said in a statement. A majority of physicians in the space have turned to off-label use of wake-promoting therapies typically used in patients with narcolepsy to help address the sleepiness issues. Idiopathic hypersomnia is a debilitating neurologic sleep disorder characterized by chronic excessive daytime sleepiness (EDS). 2 The oral solution received fast track designation from the FDA in September 2020 for this indication, and in December was granted a rolling submission, allowing for the submission of portions of the application as completed. The company announced the acceptance of its supplemental new drug application (sNDA) for JZP-258 in February, which included data from a positive phase 3 study (NCT03533114) that showed the investigational agent was effective and safe for adults with idiopathic hypersomnia. The combination agent of calcium, magnesium, potassium, and sodium oxybates will be available to patients in the fourth quarter of 2021 following Risk Evaluation and Mitigation Strategies (REMS) implementation. In no event shall The Hypersomnia Foundation be liable for any damages (including without limitation incidental and consequential damages) or costs (including without limitation attorney’s fees) based on any claim arising from the use of this website and/or its content.Jazz Pharmaceuticals announced today that the FDA has approved JZP-258 (marketed as Xywav), for the treatment of idiopathic hypersomnia, the first treatment approved for this indication. The Hypersomnia Foundation makes no representations or warranties about the satisfaction of any government regulations requiring disclosure of information on prescription drug products. Reliance on any information on this website is solely at your own risk. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Always consult your own attorney or other legal advisor with any legal questions you may have. The Hypersomnia Foundation does not recommend or endorse any specific tests, physicians, lawyers, legal advisors, products, procedures, opinions or other information referenced on this website. This website is not intended to be a substitute for professional legal or medical advice, diagnosis or treatment. The contents of this website, including text, graphics and other material, are for informational purposes only. *Members of the Hypersomnia Foundation Patient Advisory and Advocacy Council ( PAAC) who either have a hypersomnia or are supporters offer this advice (2021).īack to Advice for Living With a Hypersomnia Disclaimer If you would like to share other ways to describe IH in a Nutshell, please contact us at *protected email*. I never feel as if I have slept, no matter how much sleep I get. International Patient Registry – Join or Update Your Data.Guides for Working With People With Hypersomnias.International Healthcare Provider Directory.
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