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Jazz Pharma Announces Orphan Drug Exclusivity For Xywav To Treat Excessive Daytime Sleepiness

Jazz Pharmaceuticals plc (JAZZ) said Friday that the U.S. Food and Drug Administration has recognized seven years of Orphan Drug Exclusivity for Xywav--calcium, magnesium, potassium, and sodium oxybates-- oral solution for the treatment of cataplexy or excessive daytime sleepiness or EDS in patients 7 years of age and older with narcolepsy.

Xywav is an oxybate product with a unique composition 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 6 to 9 grams.

The FDA also published its summary of clinical superiority findings for Xywav for the treatment of cataplexy or EDS associated with narcolepsy, stating that the active moiety, oxybate, was previously approved as Xyrem for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy.

According to FDA, Xywav is clinically superior to Xyrem by means of greater safety because Xywav provides a greatly reduced chronic sodium burden compared to Xyrem.
The FDA's summary also stated that the differences in the sodium content of the two products at the recommended doses will be clinically meaningful in reducing cardiovascular morbidity in a substantial proportion of patients for whom the drug is indicated.

The FDA's Orphan Drug Designation program is designed to advance the development of drugs that treat a condition affecting 200,000 or fewer U.S. patients annually. The seven-year market exclusivity for Xywav began on July 21, 2020, the date of FDA approval.

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