Jazz Pharma Presents JZP-258 Phase 3 Study Data At World Sleep 2019

(RTTNews) - Jazz Pharmaceuticals plc (JAZZ) presented positive data from its Phase 3 study of its investigational medicine, JZP-258, for the treatment of cataplexy and excessive daytime sleepiness in adults with narcolepsy. The results from the trial were reported by the company on March 26, 2019.

Cataplexy is a sudden, uncontrollable muscle weakness, often triggered by a strong emotion.

JZP-258, a novel oxybate product candidate with a unique composition of cations, has 92% less sodium than its own Xyrem, which was approved in 2002 for the indication of cataplexy associated with narcolepsy.

Change in the weekly number of cataplexy attacks was the primary endpoint of the study. The number of cataplexy attacks in a week showed a significant increase in participants randomized to placebo compared with participants randomized to JZP-258.

The main secondary endpoint was the change in the Epworth Sleepiness Scale (ESS) score with JZP-258 compared to placebo. At the end of the double-blind withdrawal period, there was a significant increase in median ESS scores in participants randomized to placebo compared with participants randomized to JZP- 258. A higher ESS score shows a higher level of daytime sleepiness.

The data were presented at World Sleep 2019 in Vancouver, Canada. 

JAZZ closed Wednesday's trading at $130.95, down 1.47%.