US FDA Grants Orphan Drug Designation For Xywav

Release Date: 05-Sep-2021

US FDA has granted Orphan Drug Designation for Xywavandtrade; (calcium, magnesium, potassium, and sodium oxybates) oral solution for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. XYWAV can cause serious side effects such as sleepwalking, breathing and mental health problems. Xywav, also known as JZP258 is an oxybate product with a unique composition of cations resulting in 92% less sodium andndash; or around 1,000 to 1,500 mg/night andndash; than sodium oxybate at the recommended dosage range of 6 to 9 grams. It is an investigational product being evaluated for the treatment of adult patients with idiopathic hypersomnia.


There are many safety information related to XYWAV. The active ingredient of XYWAV is a form of gamma hydroxybutyrate (GHB). Abuse or misuse of illegal GHB alone or with other drugs that cause changes in consciousness and have caused serious side effects which include seizures, trouble breathing, coma, and death etc. Selling or giving XYWAV is against the law.

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