Jazz enrolls first patient in JZP-110’s phase 2 trial for excessive sleepiness in PD patients

The clinical study will be conducted across approximately 15 centers in the United States.

Jazz Pharmaceuticals research and development global head and development and chief medical officer Karen Smith, M.D., Ph.D. said: "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.

"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.