Jazz Pharmaceuticals PLC 10-Q filed Aug 3, 2026

Modified · Rare Sleep Disorders

In June 2021, FDA recognized seven years of ODE for Xywav in EDS and cataplexy in narcolepsy through July 2027 (which was subsequently extended to January 2028). NeverthelessSubsequently, Lumryz, a fixed-dose, high-sodium oxybate, was approved by FDA on May 1granted pediatric exclusivity, 2023, forwhich extends the treatmentperiod of cataplexy or EDS in adults with narcolepsy and was launched in the U.Sorphan exclusivity to January 2028. market by Avadel in June 2023. FDA continues to recognize seven years of ODE for Xywav in narcolepsy. In connection with granting ODE, FDA stated that "Xywav is clinically superior to Xyrem by means of greater safety because Xywav provides a greatly reduced chronic sodium burden compared to Xyrem.” 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." FDA has also recognized that the difference in sodium content between Xywav and Lumryz, which is a high-sodium oxybate launched in the U.S. market in June 2023, is likely to be clinically meaningful in all patients with narcolepsy and that Xywav is safer than Lumryz in all such patients. Lumryz has the same sodium content as Xyrem.