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Calcium, Magnesium, Potassium and Sodium Oxybates (Xywav®) in Sleep Disorders: A Profile of Its Use

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posted on 03.04.2022, 23:06 by Young-A Heo

Declarations

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

Authorship and Conflict of interest Young-A Heo is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability not applicable

Additional information about this Adis Drug Review can be found here


Abstract

Calcium, magnesium, potassium and sodium oxybates (Xywav®; hereafter referred to as lower-sodium oxybate), a new oxybate formulation with a greatly reduced sodium burden compared with previously approved sodium oxybate (Xyrem®), is approved for the treatment of cataplexy and excessive daytime sleepiness (EDS) in adults and children aged ≥ 7 years with narcolepsy, and is the first drug approved for the treatment of idiopathic hypersomnia in adults in the USA. In two pivotal double-blind, placebo-controlled phase 3 trials of randomized-withdrawal design, lower-sodium oxybate effectively improved EDS and cataplexy in adults with narcolepsy, and EDS and overall symptoms in adults with idiopathic hypersomnia during open-label titration and optimization periods. At the end of the double-blind, randomized withdrawal period, participants randomized to switch to placebo experienced significant worsening of these symptoms compared with those randomized to continue lower-sodium oxybate. Furthermore, worsening in patient- and clinical-rated global scales, as well as measures of health-related quality of life were also seen with placebo versus lower-sodium oxybate. Lower-sodium oxybate is generally well tolerated, with the tolerability profile being largely consistent to that seen with sodium oxybate.


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