Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced today that the first patients have been enrolled in a Phase 3 clinical development program evaluating the safety and efficacy of its investigational drug candidate, JZP-110, as a wake-promoting agent in the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy or with obstructive sleep apnea (OSA). The JZP-110 clinical development program includes three Phase 3 studies being conducted in the United States (U.S.), Canada and the European Union (EU). The program also includes an open-label extension study to evaluate the long-term safety of JZP-110.
"This R&D milestone represents another step forward in Jazz's development program for JZP-110 and in our efforts to develop new treatment options for people with narcolepsy and with other sleep disorders," said Karen Smith, M.D., Ph.D., Global Head of Research and Development and Chief Medical Officer of Jazz Pharmaceuticals. "We are excited to advance JZP-110 into Phase 3 clinical development to further evaluate it as a wake-promoting agent, and we look forward to continued collaboration with the FDA and key thought leaders as we advance development of JZP-110."
Clinical Program Study Design
Approximately 880 patients in the aggregate are expected to be enrolled in the three Phase 3 studies to be conducted across 67 medical centers in the U.S., Canada and EU. The co-primary endpoints for all three Phase 3 clinical studies -- the Maintenance of Wakefulness Test (MWT) and the Epworth Sleepiness Scale (ESS) -- will measure patients' improvement in ability to stay awake and in sleepiness. Up to 450 patients are expected to be enrolled in the open-label, long-term safety extension study. For more information on the clinical trials, go to www.clinicaltrials.gov
- Study 14-002: A 12-week, double-blind, randomized, placebo-controlled, multi-center, four-treatment parallel group study of the safety and efficacy of JZP-110 in the treatment of EDS in adult patients with narcolepsy.
- Study 14-003: A 12-week double-blind, placebo-controlled, randomized, multi-center study of the safety and efficacy of JZP-110 in the treatment of EDS in adult patients with OSA.
- Study 14-004: A six-week, double-blind, placebo-controlled, randomized-withdrawal, multi-center study of the safety and efficacy of JZP-110 in the treatment of EDS in adult patients with OSA.
- Study 14-005: A long-term (52 week) open-label safety and maintenance of efficacy study of JZP-110 in the treatment of EDS in adult patients with narcolepsy or with OSA to assess the long-term safety and maintenance of efficacy in patients.
"People living with EDS associated with narcolepsy and patients with unresolved EDS in OSA often experience an inadequate response to, or have difficulty tolerating, their currently prescribed wake-promoting treatment, underscoring the need for new treatment options. The Phase 3 clinical development program will further define the clinical profile of JZP-110 as a potential alternative for these patients," said Richard Bogan, M.D., Associate Clinical Professor at the University of South Carolina School of Medicine and Chief Medical Officer of SleepMed Inc.