Xywav
| Combination of | |
|---|---|
| Calcium oxybate | CNS depressant |
| Magnesium oxybate | CNS depressant |
| Potassium oxybate | CNS depressant |
| Sodium oxybate | CNS depressant |
| Clinical data | |
| Trade names | Xywav |
| License data | |
| Routes of administration | By mouth |
| ATC code |
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| Legal status | |
| Legal status |
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| Identifiers | |
| KEGG | |
Calcium oxybate/magnesium oxybate/potassium oxybate/sodium oxybate, sold under the brand name Xywav, is a medication used to treat cataplexy or excessive daytime sleepiness (EDS).[1][2] It contains a mixture of oxybate salts, calcium oxybate, magnesium oxybate, potassium oxybate, and sodium oxybate.[1] It is taken by mouth.[1]
It was approved for medical use in the United States in July 2020.[1][3][4]
Medical uses
Calcium oxybate/magnesium oxybate/potassium oxybate/sodium oxybate is indicated for the treatment of cataplexy in people aged seven years of age and older with narcolepsy.[1][5]
In August 2021, the U.S. Food and Drug Administration (FDA) approved calcium oxybate/magnesium oxybate/potassium oxybate/sodium oxybate for the treatment of idiopathic hypersomnia.[5][6]
Society and culture
Legal status
Calcium oxybate/magnesium oxybate/potassium oxybate/sodium oxybate was granted orphan drug designation in November 1994 by the U.S. Food and Drug Administration (FDA).[7][5] The FDA granted the approval of Xywav to Jazz Pharmaceuticals plc.[5]
References
- 1 2 3 4 5 6 "Xywav (- calcium, magnesium, potassium, and sodium oxybates solution". DailyMed. Retrieved 12 August 2021.
- ↑ Halter MJ, Fratena CA (13 November 2021). "Sleep-Wake Medications". Varcarolis' Manual of Psychiatric Nursing Care. Elsevier Health Sciences. p. 398. ISBN 978-0-323-79306-3.
- ↑ "Drug Approval Package: Xywav". U.S. Food and Drug Administration (FDA). 7 May 2021. Retrieved 12 August 2021.
- ↑ "Drug Approval Package: Xywav". U.S. Food and Drug Administration (FDA). 7 May 2021. Retrieved 19 November 2021.
- 1 2 3 4 "FDA Grants First of its Kind Indication for Chronic Sleep Disorder Treatment". U.S. Food and Drug Administration (FDA) (Press release). 12 August 2021. Retrieved 12 August 2021.
- ↑ "Jazz Pharmaceuticals Announces U.S. FDA Approval of Xywav (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for Idiopathic Hypersomnia in Adults" (Press release). Jazz Pharmaceuticals. 12 August 2021. Retrieved 12 August 2021 – via PR Newswire.
- ↑ "Xywav Orphan Drug Designations and Approvals". U.S. Food and Drug Administration (FDA). Retrieved 12 August 2021.
External links
- "F.D.A. Approves GHB, a 'Date Rape' Drug, for Narcolepsy Patients". The New York Times. 12 August 2021.