Sodium oxybate extended-release suspension (LUMRYZ™) in narcolepsy: a profile of its use

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Funding The preparation of this review was not supported by any external funding.

Authorship and conflict of interest Hannah Blair is a salaried employee of Adis International Ltd/Springer Nature and declares no relevant conflicts of interest. All authors contributed to this article and are responsible for its content.

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Additional information about this Adis Drug Review can be found here. 

Abstract Sodium oxybate extended-release suspension (LUMRYZ™; hereafter referred to as sodium oxybate ER) represents a promising novel option for the treatment of narcolepsy. It is the first once-nightly sodium oxybate formulation to be approved in the USA for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. Sodium oxybate ER has a pharmacokinetic profile that supports a single bedtime dose. In a pivotal phase 3 trial, once-nightly sodium oxybate ER dose-dependently increased sleep latency during the daytime, reduced cataplexy and daytime sleepiness, and improved disrupted nighttime sleep (DNS) compared with placebo in patients aged ≥ 16 years with narcolepsy. These improvements were statistically significant and clinically meaningful. Most patients who switched from twice-nightly immediate-release sodium oxybate (hereafter referred to as sodium oxybate IR) to once-nightly sodium oxybate ER in an open-label extension/switching study preferred the once-nightly formulation. Once-nightly sodium oxybate ER was generally well tolerated, including over the longer term, with a tolerability profile consistent with that of twice-nightly sodium oxybate IR.

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