Jazz Pharmaceuticals plc 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,” says Karen Smith, MD, PhD, global head of research and development and chief medical officer of Jazz Pharmaceuticals, in a release. “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.
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 obstructive sleep apnea (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. The JZP-110 clinical program includes two Phase 3 studies evaluating ES in adult patients with OSA, one Phase 3 study evaluating ES in adult patients with narcolepsy, and an open label long-term safety study. Patient enrollment in the OSA and narcolepsy studies is complete and enrollment in the open-label study is ongoing.