EDS is characterized by the inability to stay awake and alert during the day resulting in drowsiness and unplanned lapses into sleep.
Cataplexy occurs in about 70 percent of people with narcolepsy. The most specific symptom of narcolepsy is the sudden band brief (<2 minutes) loss of muscle tone with retained consciousness. It is triggered by strong emotions such as laughter, surprise or anger. Although many emotions can potentially trigger cataplexy, those associated with mirth are usually the most potent. Presentation differs widely among people with narcolepsy ranging from sporadic partial attacks triggered by laughter to frequent complete collapse brought about by a variety of emotions. Complete collapse is less common. More commonly episodes of cataplexy involve only certain muscle groups such as arms and legs (e.g., knees buckling), the head and neck (e.g., head dropping) or the face and jaw (e.g., sagging, slurred speech, eyelid drooping).
Narcolepsy is a chronic neurologic condition. It has no cure and the illness burden can have a far-reaching impact on a patient’s health over time. As an established leader in sleep medicine, Jazz is committed to raising awareness about narcolepsy and helping patients find strategies to manage this sleep disorder.
The Product, Xywav
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. The approval of Xywav was based on results from a global Phase 3 double-blind, placebo-controlled, randomized-withdrawal, multicenter study.
The results confirmed the efficacy and the safety of Xywav in treating cataplexy and EDS in patients with narcolepsy. These results are statistically significant compared to placebo.
Jazz Pharmaceuticals intends to launch Xywav by the end of the year following Risk Evaluation and Mitigation Strategy (REMS) implementation. Jazz Pharmaceuticals stated that it will work to secure the broadest access possible for appropriate patients.
Richard K. 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, explained, “Xywav makes it possible for patients to have a lower-sodium oxybate treatment option, which could help patients taking sodium oxybate better align with daily sodium intake recommendations including those by the American Heart Association. The average American consumes too much sodium. Excess sodium intake has been linked with increases in blood pressure, hypertension, stroke, and other cardiovascular diseases.”
The only approved product for both cataplexy and EDS in patients with narcolepsy 7 years of age and older and designated as a standard of care has been Sodium oxybate which carries warnings about its high sodium content.
Jazz Pharmaceuticals’ Xywav was developed to provide narcolepsy patients with an oxybate therapy that is lower in sodium. The product does not carry warnings about sodium content.
Safety and Adverse Effects of Xywav
Xywav has a Boxed Warning as a central nervous system depressant and for its potential for abuse and misuse. Because of the risks of CNS depression, abuse and misuse Xywav is available only through a restricted program under a program called Xyrem REMS Program. The most common adverse reactions in adults (≥5%) were headache, nausea, dizziness, decreased appetite, parasomnia, diarrhea, hyperhidrosis, anxiety and vomiting.
Julie Flygare, President and CEO of Project Sleep, said, “Many people with narcolepsy can go years before being properly diagnosed and this can have a significant impact on their everyday life. Narcolepsy is a life-long condition so it is important to have new options to help treat EDS and cataplexy.”
The U.S. Drug Enforcement Agency (DEA) has designated Xywav as a Schedule III medicine. The DEA defines Schedule III drugs, substances or chemicals as drugs with a moderate to low potential for physical and psychological dependence.
More information about Xywav, including Full Prescribing Information and Medication Guide, is available at http://pp.jazzpharma.com/pi/xywav.en.USPI.pdf.
It is extremely important for adults and parents of the children prescribed with Xywav to not only carefully listen to the specialists’ instructions but to also ask for and read the instructions that contain the warnings, the adverse effects and the interactions of the product.
The approval of Xywav is a gift with great benefit to be offered to children suffering from narcolepsy complications, including cataplexy or EDS. The approval has also re-energized Jazz Pharmaceuticals’ stock and its holders.
The stock is trading today at $109.92, UP $4.40.
To read more about our coverage of Jazz Pharmaceuticals please click here.
Jazz Pharmaceuticals: A New FDA Approval
People living with narcolepsy who develop cataplexy and excessive daytime sleepiness have a new treatment called Xywav, from Jazz Pharmaceuticals.
Jazz Pharmaceuticals NEWS
On July 21, 2020 the U.S. FDA approved Jazz Pharmaceuticals’ (JAZZ) product Xywav™ (calcium, magnesium, potassium and sodium oxybates) oral solution for the treatment of cataplexy and excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.
Narcolepsy is a chronic, debilitating neurological disorder characterized by EDS and an inability to normally regulate sleep-wake cycles. It affects an estimated one in 2,000 people in the United States with symptoms typically appearing in childhood or adolescence. Studies have shown it may take 10 years or more for people with narcolepsy to receive a diagnosis. The five main symptoms of narcolepsy include: EDS, cataplexy, disturbed nighttime sleep, sleep-related hallucinations and sleep paralysis. Narcolepsy is associated with obesity, hypertension, diabetes and hypercholesterolemia.