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
Jazz Pharmaceuticals’ Xywav for Cataplexy and Narcolepsy. (Credit: PRNewsfoto/Jazz Pharmaceuticals plc)
Jazz Pharmaceuticals has received the US Food and Drug Administration (FDA) approval for Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution to treat cataplexy or excessive daytime sleepiness (EDS) and narcolepsy.
Xywav is an oxybate product composed of cations resulting in 92% less sodium, or approximately 1,000 to 1,500 mg/night, than sodium oxybate at the recommended dosage range of six to nine grams.
Xywav is s a central nervous system depressant, and the US Drug Enforcement Agency (DEA) has designated Xywav as a Schedule III medicine, defined as substances with a moderate to low potential for physical and psychological dependence.
Jazz Pharmaceuticals chairman and CEO Bruce Cozadd said: “We have been working for nearly a decade to develop Xywav, a unique oxybate product with a significant reduction in sodium.
“We are proud to advance the science behind our sleep research program in order to continue making a difference for people living with narcolepsy. Jazz is committed to addressing unmet needs in sleep medicine, which includes our innovative and long-standing oxybate programme.”
The FDA approval of Xywav is based on data from the Phase 3 clinical trial
The US regulatory approval of Xywav is supported by the data from on a global Phase 3 double-blind, placebo-controlled, randomised-withdrawal, multicentre clinical trial.
The Phase 3 study enrolled 201 patients with narcolepsy and demonstrated the efficacy and safety of Xywav for the treatment of cataplexy and EDS.
In the clinical trial, the drug has shown highly significant differences in the number of cataplexy attacks and Epworth Sleepiness Scale scores in a week, compared to placebo.
The company is offering Xywav with multiple dosing options for adult and pediatric patients, where prescribers can titrate the drug into unequal doses taken over the course of the night.
Patients taking Xywav after sodium oxybate, are advised to initiate the treatment at the dose and regimen similar to sodium oxybate and titrated as per requirement based on efficacy and tolerability.
Jazz Pharmaceuticals intends to commercialise the drug by the end of 2020, following risk evaluation and mitigation strategy (REMS) implementation.
Phase 3 study lead investigator Richard K Bogan said: “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. Xywav makes it possible for patients to have a lower-sodium oxybate treatment option.
“This may 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.5 Excess sodium intake has been linked with increases in blood pressure, hypertension, stroke, and other cardiovascular diseases.”