The US Food and Drug Administration (FDA) has approved an oral solution of calcium, magnesium, potassium, and sodium oxybates (Xywav, Jazz Pharmaceuticals) for treatment of cataplexy or excessive daytime sleepiness (EDS) in patients as young as age 7 years with narcolepsy.
Xywav is a novel oxybate product with a unique composition of cations, resulting in 92% less sodium than sodium oxybate (Xyrem, Jazz Pharmaceuticals) at the recommended dosage range of 6 to 9 grams, the company said in a news release.
The FDA approved the drug based on a phase 3 trial involving 201 patients who had narcolepsy with cataplexy.
The overall safety profile of Xywav is in line with sodium oxybate, the company said. The most common adverse reactions in adults, occurring in at least 5% of participants, were headache, nausea, dizziness, decreased appetite, parasomnia, diarrhea, hyperhidrosis (excessive sweating), anxiety, and vomiting.
Xywav has a boxed warning as a CNS depressant and for its potential for abuse and misuse. As a result, the drug is only available through a Risk Evaluation and Mitigation Strategy (REMS) program.
The US Drug Enforcement Agency has designated Xywav as a schedule III drug, meaning it has a moderate to low potential for physical and psychological dependence.
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