First Patient Enrolled in Phase 2 Clinical Study Evaluating JZP-110 for Excessive Sleepiness in Parkinson’s Disease

February 22, 2017

Jazz Pharmaceuticals plc announced that the first patient has been enrolled in a Phase 2 clinical study evaluating JZP-110, a selective dopamine and norepinephrine reuptake inhibitor, as a potential treatment for excessive sleepiness (ES) in adult patients with Parkinson’s disease. The clinical study will be conducted across approximately 15 centers in the United States.

“Excessive sleepiness is a debilitating symptom of Parkinson’s disease, and we are interested in determining whether the wake-promoting effects of JZP-110 could be beneficial in this patient population,” says Karen Smith, MD, PhD, global head of research and development and chief medical officer of Jazz Pharmaceuticals, in a release. “The initiation of this study is another step forward in our development program for JZP-110 and our efforts to develop new treatment options for people with sleep disorders.”

The Phase 2 study is a double-blind, placebo-controlled, randomized, multicenter, crossover study evaluating the safety, efficacy, and pharmacokinetics of JZP-110 in adult patients with Parkinson’s disease and ES. The study is expected to enroll approximately 50 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 Phase 3 clinical program includes two studies evaluating ES in adult patients with OSA, one 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.

http://www.sleepreviewmag.com/2017/02/first-patient-enrolled-phase-2-clinical-study-evaluating-jzp-110-excessive-sleepiness-parkinsons-disease/