We are proud to advance the science behind our sleep research program in order to continue making a difference for people living with narcolepsy,” said Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals. “We have been working for nearly a decade to develop Xywav, a unique oxybate product with a significant reduction in sodium. Most common adverse reactions in adults (≥5%) were headache, nausea, dizziness, decreased appetite, parasomnia, diarrhea, hyperhidrosis, anxiety and vomiting. Because of the risks of CNS depression and abuse and misuse, Xywav is available only through a restricted program under a REMS called the Xywav and Xyrem REMS Program.
Xywav has a Boxed Warning as a central nervous system depressant, and for its potential for abuse and misuse.
12 With the goal of establishing a new standard of care, Xywav was developed to provide people with narcolepsy an oxybate therapy with lower sodium, and does not carry warnings about sodium content. Sodium oxybate carries warnings about its high sodium content, 10 and was previously the only product approved to treat both cataplexy and EDS in patients with narcolepsy 7 years of age and older 11 and designated as a standard of care for the treatment of cataplexy and EDS by the American Academy of Sleep Medicine. 5 Excess sodium intake has been linked with increases in blood pressure, hypertension, stroke, and other cardiovascular disease. “The average American consumes too much sodium. Bogan, MD, FCCP, FAASM, associate clinical professor at the University of South Carolina School of Medicine, a medical officer at SleepMed in Columbia, SC and lead investigator of the Phase 3 study. This may help patients taking sodium oxybate better align with daily sodium intake recommendations including those by the American Heart Association, 4” said Richard K. 1 Xywav makes it possible for patients to have a lower-sodium oxybate treatment option. “Based on the efficacy demonstrated in the clinical program, the approval of Xywav is important for people living with cataplexy or EDS associated with narcolepsy. When patients start Xywav after sodium oxybate, Xywav treatment is initiated at the same dose and regimen as sodium oxybate (gram for gram) and titrated as needed based on efficacy and tolerability. Prescribers can titrate Xywav into unequal doses taken over the course of the night.
Multiple Xywav dosing options are available for adult and pediatric patients. In the study, which enrolled 201 patients, Xywav demonstrated highly statistically significant differences (p<0.0001) in weekly number of cataplexy attacks and Epworth Sleepiness Scale scores compared to placebo. The 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. Jazz is committed to ensuring access to our medicines and will work to secure the broadest access possible for appropriate patients. The company plans to launch Xywav by the end of the year following Risk Evaluation and Mitigation Strategy (REMS) implementation. 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.
Food and Drug Administration (FDA) approved Xywav™ (calcium, magnesium, potassium, and sodium oxybates) oral solution on Jfor the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. Jazz Pharmaceuticals plc announced that the U.S.
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