Abstract

What is this summary about? This plain language summary describes a clinical study that looked at the effects of a medicine called low-sodium oxybate (or LXB; XYWAV® [calcium, magnesium, potassium, and sodium oxybates]) in adults with narcolepsy. Narcolepsy is a rare brain disorder that can make people feel extremely sleepy during the day or have symptoms like cataplexy, which is sudden and temporary muscle weakness. This study compared changes in symptoms between people who either switched to placebo or continued with LXB after they had been taking LXB for 14 weeks. The placebo looked and tasted like LXB but did not have the active ingredient. This allowed researchers to see if LXB improved symptoms like cataplexy and extreme daytime sleepiness. What were the results? Cataplexy and daytime sleepiness got worse in people who switched to placebo compared with those who kept taking LXB. This means that LXB worked well to treat symptoms of cataplexy and extreme daytime sleepiness. The most common side effects–defined as any unexpected medical events that happened while taking LXB–were headache, nausea, and dizziness. What do the results mean? LXB lowered the symptoms of cataplexy and daytime sleepiness in people with narcolepsy. LXB is approved in the USA to treat cataplexy or extreme daytime sleepiness (in people with narcolepsy who are 7 years of age and older). LXB is approved in Canada to treat cataplexy in adults with narcolepsy.

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