FDA grants orphan drug status to Xywav, citing “greatly reduced chronic sodium exposure compared to Xyrem”


Sleep Treatments | Sleep Review

The U.S. Food and Drug Administration (FDA) has orphaned the oral solution Xywav (calcium, magnesium, potassium, and sodium oxybates) from Jazz Pharmaceuticals plc for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients – Exclusivity recognized 7 years and older with narcolepsy. Xywav is an oxybate product with a composition of cations that provides 92% less sodium – or approximately 1,000 to 1,500 mg / night – than sodium oxybate in the recommended dosage range of 6 to 9 grams.

The FDA also released its summary of the clinical superiority results of Xywav for the treatment of cataplexy or excessive daytime sleepiness associated with narcolepsy, noting that “the active component oxybate was previously approved as Xyrem (sodium oxybate) for the treatment of cataplexy or EDS”. in patients aged 7 and over with narcolepsy. ”According to the FDA,“ Xywav (calcium, magnesium, potassium and sodium oxybate) is clinically superior to Xyrem due to its higher safety, as Xywav offers a greatly reduced chronic sodium exposure compared to Xyrem. ”In the summary the FDA also states that “the differences in sodium content of the two products at the recommended doses will be clinically important in reducing cardiovascular morbidity in a significant proportion of patients for whom the drug is indicated.”

[RECOMMENDED: What We Know About Narcolepsy, Sodium Oxybate Use, Salt Intake & Cardiovascular Risk]

Robert Iannone, MD, MSCE, Executive Vice President, Research and Development and Chief Medical Officer of Jazz Pharmaceuticals, said in a press release, “We are pleased that the FDA has recognized the greater safety of Xywav due to its greatly reduced chronic sodium exposure. This action is in line with the FDA’s long-established position on the benefits of reducing daily sodium intake. As a long-time leader in sleep medicine, we are aware of the many challenges that patients with narcolepsy face, including the increased risk of cardiometabolic comorbidities such as obesity, high blood pressure, diabetes and hypercholesterolemia. We are encouraged that the FDA has recognized the benefits of reducing sodium in a chronic drug for these patients. We took the low-sodium Xywav from concept to commercial availability to demonstrate the maturity of Jazz and provide a much-needed drug for patients in critical need. “

The FDA’s orphan drug designation program is designed to advance the development of drugs that treat a condition that affects 200,000 or fewer US patients annually. The seven-year market exclusivity for Xywav began on July 21, 2020, the day of FDA approval.

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