JZP-258
Neurology· 149 cited findings· 1 source document
Company: Jazz Pharmaceuticals plc →
What the regulatory reviews say
JZP-258 is a drug indicated for the treatment of cataplexy and excessive daytime sleepiness in patients 7 years of age and older with narcolepsy. The New Drug Application (NDA 212690) for JZP-258 was approved on July 21, 2020.
In a double-blind, placebo-controlled, randomized withdrawal multicenter study (Study 15-006), JZP-258 demonstrated statistically significant superiority for its primary efficacy endpoint, weekly cataplexy attacks (p < 0.0001). The mean change in weekly cataplexy attacks was 0.12 for JZP-258 treated patients compared to 11.46 for placebo. For the key secondary efficacy endpoint, Epworth Sleepiness Scale score, JZP-258 also showed statistically significant superiority (p < 0.0001), with a mean change of 0.0 compared to 3.0 for placebo.
The safety profile of JZP-258 was not substantially different from Xyrem. During the main study, there were no deaths. Serious adverse events occurred in 4 (2%) JZP-258 treated patients. Discontinuations due to adverse events were observed in 21 (10.4%) JZP-258 treated patients.
Key figures — cited to the source page
| Mean change in weekly cataplexy attacks (JZP-258) | 0.12 | Xywav FDA Review, p.6 |
| Mean change in weekly cataplexy attacks (placebo) | 11.46 | Xywav FDA Review, p.6 |
| P-value for change in weekly cataplexy attacks | < 0.0001 | Xywav FDA Review, p.6 |
| Change in modified Epworth Sleepiness Scale score (JZP-258) | 0.0 | Xywav FDA Review, p.6 |
| Change in modified Epworth Sleepiness Scale score (placebo) | 3.0 | Xywav FDA Review, p.6 |
| P-value for change in modified Epworth Sleepiness Scale score | < 0.0001 | Xywav FDA Review, p.6 |
| Serious adverse events (JZP-258 treated patients) | 2 % | Xywav FDA Review, p.39 |
| Recommendation for approval | approved | Xywav FDA Review, p.3 |
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.