Jazz Pharmaceuticals (JAZZ) Completes Enrollment of JZP-110 Phase 3 as Obstructive Sleep Apnea Treatment
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Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced that patient enrollment has been completed for its two Phase 3 studies evaluating JZP-110 in excessive sleepiness (ES) associated with obstructive sleep apnea (OSA).
"We are pleased to have reached this important milestone in our Phase 3 program," said Karen Smith, M.D., Ph.D., global head of research and development and chief medical officer of Jazz Pharmaceuticals. "We look forward to reporting the top-line results from the two OSA studies in the first quarter of 2017."
The two Phase 3 OSA studies enrolled approximately 654 patients. Both studies were double-blind, placebo-controlled, multiple-center studies evaluating the safety and efficacy of JZP-110 in the treatment of ES in adult patients with OSA. Study 14-003 evaluated four doses of JZP-110 or placebo for a 12-week period and study 14-004 was a six-week, flexible-dose, randomized withdrawal study. The studies have co-primary endpoints of the Epworth Sleepiness Scale (ESS) and the Maintenance of Wakefulness Test (MWT). These are validated endpoints, used in clinical practice, to measure the severity of excessive sleepiness and ability to stay awake in patients.
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