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 cataplexy and EDS in adults with narcolepsy, and EDS and overall idiopathic hypersomnia 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 in 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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Authors | Young-A Heo |
Journal | CNS drugs
(CNS Drugs)
Vol. 36
Issue 5
Pg. 541-549
(05 2022)
ISSN: 1179-1934 [Electronic] New Zealand |
PMID | 35357671
(Publication Type: Journal Article, Randomized Controlled Trial)
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Copyright | © 2022. Springer Nature. |
Chemical References |
- Sodium Oxybate
- Sodium
- Magnesium
- Potassium
- Calcium
|
Topics |
- Adult
- Calcium
(therapeutic use)
- Cataplexy
(drug therapy)
- Child
- Disorders of Excessive Somnolence
(drug therapy)
- Humans
- Idiopathic Hypersomnia
(drug therapy)
- Magnesium
(therapeutic use)
- Narcolepsy
(drug therapy)
- Potassium
(therapeutic use)
- Quality of Life
- Sodium
(therapeutic use)
- Sodium Oxybate
(adverse effects)
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