Jazz Pharmaceuticals (JAZZ) Achieves New Milestone in JZP-110 Phase 3 for Excessive Sleepiness in Narcolepsy
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Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced that patient enrollment has been completed in its Phase 3 study evaluating JZP-110 in excessive sleepiness (ES) associated with narcolepsy.
"This is an important milestone in our JZP-110 Phase 3 program," said Karen Smith, M.D., Ph.D., global head of research and development and chief medical officer of Jazz Pharmaceuticals. "We expect to report the top-line results from our two Phase 3 studies evaluating ES in obstructive sleep apnea in the first quarter of 2017 and the top-line results from this Phase 3 narcolepsy study in the second quarter of 2017."
The Phase 3 narcolepsy study was a double-blind, placebo-controlled, multiple-center study evaluating the safety and efficacy of JZP-110 in the treatment of ES in adult patients with narcolepsy. The study enrolled 240 patients. The co-primary endpoints were the Maintenance of Wakefulness Test and the Epworth Sleepiness Scale. These are validated endpoints, commonly used in clinical trials, that measure the ability to stay awake and the severity of excessive sleepiness, respectively, in patients.
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