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Jazz Pharmaceuticals Announces U.S. FDA Approval of Xywav™ (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for Cataplexy or Excessive Daytime Sleepiness Associated with Narcolepsy
Xywav is the first FDA approved new treatment option indicated for both cataplexy and excessive daytime sleepiness in people living with narcolepsy in more
About this update from Jazz Pharmaceuticals Plc
[{"type":"text","content":"Xywav is the first FDA approved new treatment option indicated for both cataplexy and excessive daytime sleepiness in people living with narcolepsy in more than 15 years\n Xywav contains 92 percent less sodium per nightly dose than sodium oxybate, a current standard of care for this patient population as designated by the American Academy of Sleep Medicine Guidelines\n Narcolepsy is a chronic sleep disorder and is associated with an increased prevalence of certain comorbid conditions, including hypertension and cardiovascular disease\n\n\nDUBLIN, July 22, 2020 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) approved Xywav™ (calcium, magnesium, potassium, and sodium oxybates) oral solution on July 21, 2020 for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.1,2 Xywav is an oxybate product with a unique composition of cations resulting in 92 percent less sodium – or approximately 1,000 to 1,500 mg/night – than sodium oxybate at the recommended dosage range of 6 to 9 grams.1\nThe company plans to launch Xywav by the end of the year following Risk Evaluation and Mitigation Strategy (REMS) implementation. Jazz is committed to ensuring access to our medicines and will work to secure the broadest access possible for appropriate patients.\nThe FDA approval of Xywav is based on a global Phase 3 double-blind, placebo-controlled, randomized-withdrawal, multicenter study that demonstrated the efficacy and safety of Xywav in the treatment of cataplexy and EDS in patients with narcolepsy. In the study, which enrolled 201 patients, Xywav demonstrated highly statistically significant differences (p","length":2009,"tagName":"div"}]