Jazz Pharmaceuticals plc 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,” says Karen Smith, MD, PhD, global head of research and development and chief medical officer of Jazz Pharmaceuticals, in a release. “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).
JZP-110 is a selective dopamine and norepinephrine reuptake inhibitor (DNRI) in late-stage development for treatment of ES in adult patients with narcolepsy or OSA. Jazz Pharmaceuticals has worldwide development, manufacturing, and commercialization rights to JZP-110, excluding certain jurisdictions in Asia. JZP-110 has orphan drug designation in the United States for narcolepsy.