There was a statistically significant reduction in the cataplexy that patients were experiencing. In addition to that, they looked at cataplectic episodes and showed that the number of cataplectic episodes were reduced. They showed significant improvements in the Maintenance of Wakefulness Tests, indicating that patients are able to remain more awake and alert during the day after receiving the once-nightly form of sodium oxybate at night. The prime outcome measure was an objective measure of sleepiness called the Maintenance of Wakefulness Test. What they looked at was the effect on sleepiness during the daytime. The study that was done was a parallel design study comparing placebo against FT218. So this new medication, FT218, is a once-nightly formulation of sodium oxybate the patient takes it prior to going to bed at night and then the 1 dose will serve them through the night and relieve their daytime symptoms of narcolepsy. But one of the difficulties with the medication is that it needs to be taken twice at night and many patients don't want to wake up in the middle of a night to take a second dose of the medication. Sodium oxybate we've had available to us since 2002, so we have a lot of experience with it. It was with this medication called FT218, which is a once-nightly form of sodium oxybate. The REST-ON trial is a trial that was done by a pharmaceutical company called Avadel. Food and Drug Administration.At SLEEP 2022, Michael Thorpy, MD, director of the Sleep-Wake Disorders Center at Montefiore Medical Center and professor of neurology at Albert Einstein College of Medicine, discussed the results of the REST-ON trial, which focused on the effects of FT218 in patients with narcolepsy.Ĭan you discuss the results of the REST-ON trial? Other symptoms can include cataplexy, which is a sudden loss in muscle tone triggered by strong emotion. Narcolepsy is a sleep disorder that causes daily periods of excessive daytime sleepiness. Drug Enforcement Agency has designated it a Schedule III medicine with a moderate to low potential for physical and psychological dependence. Jazz expects Xywav to be available by the end of the year. 20, 2020, that the results of the clinical trial were published online in the journal Sleep. Results show statistically significant differences in the weekly number of cataplexy attacks and Epworth Sleepiness Scale scores compared with a placebo. Jazz reports that the FDA approval of Xywav is based on a global Phase 3 double-blind, placebo-controlled, randomized-withdrawal, multicenter study of 201 patients. The most common adverse reactions to Xywav, occurring in 5 percent of adults or more, were headache, nausea, dizziness, decreased appetite, parasomnia, diarrhea, hyperhidrosis, anxiety, and vomiting. Therefore, it is available only through a restricted program. Jazz notes that Xywav has a boxed warning as a central nervous system depressant due to its potential for abuse and misuse. Current AASM practice parameters for the treatment of narcolepsy and other hypersomnias of central origin state that sodium oxybate is effective for treatment of cataplexy, daytime sleepiness, and disrupted sleep due to narcolepsy. About XywavĪccording to Jazz, Xywav is an oxybate product with a unique composition resulting in 92 percent less sodium than the recommended dosage range of sodium oxybate. Multiple Xywav dosing options are available for adult and pediatric patients. Food and Drug Administration has approved the Xywav oral solution for the treatment of cataplexy or excessive daytime sleepiness in patients with narcolepsy who are 7 years of age and older. Jazz Pharmaceuticals announced July 22, 2020, that the U.S. Guiding Principles for Industry Support.Young Investigators Research Forum (YIRF).
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