FDA okays low-sodium treatment option for narcolepsy

FDA okays low-sodium treatment option for narcolepsy

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Fri, 07/24/2020 – 16:00

FDA approved an oral solution of calcium, magnesium, potassium, and sodium oxybates (Xywav—Jazz Pharmaceuticals) for the treatment of cataplexy or excessive daytime sleepiness (EDS) in narcolepsy patients as young as age 7 years. The treatment 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 6-9 grams. FDA approved the drug based on a Phase III trial involving 201 narcolepsy patients with cataplexy. The new oral solution demonstrated statistically significant differences in weekly number of cataplexy attacks and Epworth Sleepiness Scale scores compared with placebo. Lead investigator Richard K. Bogan, MD, University of South Carolina School of Medicine, says the new treatment “makes it possible for patients to have a lower-sodium oxybate treatment option. This may help patients taking sodium oxybate better align with daily sodium intake recommendations, including those by the American Heart Association.” The most common adverse events in adults, occurring in at least 5% of participants, were headache, nausea, dizziness, decreased appetite, parasomnia, diarrhea, hyperhidrosis, anxiety, and vomiting. The treatment carries a boxed warning as a central nervous system depressant and for potential abuse and misuse, and has been designated by DEA as a schedule III drug.