Low-Sodium Oxybate Improved Symptoms in Adults with Narcolepsy with Cataplexy: A Plain Language Summary of Publication

Plain Language Summary

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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Keywords::

• cataplexy
• lay summary
• Narcolepsy
• oxybate
• plain language summary
• sleepiness
• sodium

Acknowledgments

The authors would like to thank the people who participated in this study, as well as their families.

Financial disclosure

RK Bogan has served on the speakers’ bureau and participated in advisory boards for Jazz Pharmaceuticals and Harmony Biosciences and has received research/grant support from Jazz Pharmaceuticals, Harmony Biosciences, Balance Therapeutics, Axsome Therapeutics, Merck, and Avadel Pharmaceuticals. MJ Thorpy has received research/grant support and consultancy fees from Jazz Pharmaceuticals, Harmony Biosciences, Balance Therapeutics, Axsome Therapeutics, and Avadel Pharmaceuticals. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Competing interests disclosure

N Foldvary-Schaefer has served on an advisory committee for Jazz Pharmaceuticals and participated in clinical trials for Suven, Takeda, and Vanda. W Macfadden is an employee of Jazz Pharmaceuticals who, in the course of his employment, has received stock options exercisable for, and other stock awards of, ordinary shares of Jazz Pharmaceuticals plc. M Gow is the co-founder and executive director of Wake Up Narcolepsy, a 501(c)(3) not-for-profit organization. The authors have no other competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript apart from those disclosed.

Writing disclosure

Under the direction of the authors, Benjamin Hiller, PhD, and Emily Bruggeman, PhD, of Peloton Advantage, LLC, an OPEN Health company, provided medical writing and editorial support for this manuscript, which was funded by Jazz Pharmaceuticals.

Additional information

Funding

RK Bogan has served on the speakers’ bureau and participated in advisory boards for Jazz Pharmaceuticals and Harmony Biosciences and has received research/grant support from Jazz Pharmaceuticals, Harmony Biosciences, Balance Therapeutics, Axsome Therapeutics, Merck, and Avadel Pharmaceuticals. MJ Thorpy has received research/grant support and consultancy fees from Jazz Pharmaceuticals, Harmony Biosciences, Balance Therapeutics, Axsome Therapeutics, and Avadel Pharmaceuticals. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.