Xyrem(Sodium Oxybate)
Neurology· 590 cited findings· 1 source document
Company: Jazz Pharmaceuticals plc →
What the regulatory reviews say
Xyrem (Sodium Oxybate) is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older. It is a Schedule III controlled substance.
In clinical trials, Xyrem demonstrated a statistically significant reduction in weekly cataplexy attacks. The median change from baseline in weekly cataplexy attacks was 0.27 in the Xyrem arm compared to 12.71 in the placebo arm (p-value <0.0001). The mean change in weekly cataplexy attacks was 2.52 for Xyrem versus 17.37 for placebo (p-value < 0.0001). A nominally statistically significant difference was also observed between treatment groups on Patient Global Impression of Change for narcolepsy severity overall.
Common side effects in adults include nausea, dizziness, vomiting, somnolence, enuresis, and tremor. In pediatric patients, common side effects include enuresis, nausea, headache, vomiting, weight decreased, decreased appetite, and dizziness. Xyrem is contraindicated with alcohol and sedative hypnotics. A Risk Evaluation and Mitigation Strategy (REMS) program is required for Xyrem, and patients should avoid hazardous activities for 6 hours after dosing. The maximum recommended dose is 9 g/night.
Key figures — cited to the source page
| Median change from baseline in weekly cataplexy attacks (Xyrem arm, final analysis) | 0.27 | JAZZ PHARMS — Xyrem FDA Review, p.349 |
| Median change from baseline in weekly cataplexy attacks (Placebo arm, final analysis) | 12.71 | JAZZ PHARMS — Xyrem FDA Review, p.349 |
| p-value for treatment difference in weekly cataplexy attacks (final analysis) | <0.0001 | JAZZ PHARMS — Xyrem FDA Review, p.349 |
| Most commonly observed side effects in adult patients | nausea, dizziness, vomiting, somnolence, enuresis, and tremor | JAZZ PHARMS — Xyrem FDA Review, p.185 |
| Contraindications | Alcohol and sedative hypnotics | JAZZ PHARMS — Xyrem FDA Review, p.102 |
| Controlled substance schedule | Schedule III | JAZZ PHARMS — Xyrem FDA Review, p.102 |
| Time to avoid hazardous activities after dosing | 6 | JAZZ PHARMS — Xyrem FDA Review, p.108 |
| Minimum age for use | 7 | JAZZ PHARMS — Xyrem FDA Review, p.102 |
Source documents
Explore the full evidence
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.