DUBLIN, Sept. 26, 2016 /PRNewswire/ -- Jazz
Pharmaceuticals plc (Nasdaq: JAZZ) today 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," said Karen Smith,
M.D., Ph.D., global head of research and development and chief
medical officer of Jazz Pharmaceuticals. "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).
These are validated endpoints, used in clinical practice, to
measure the severity of excessive sleepiness and ability to stay
awake in patients.
About JZP-110
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.
The JZP-110 clinical program includes two additional studies:
the Phase 3 safety and efficacy study evaluating JZP-110 for the
treatment of ES in narcolepsy and the open label long-term safety
study. Enrollment in these studies is ongoing.
About Jazz Pharmaceuticals
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is an international
biopharmaceutical company focused on improving patients' lives by
identifying, developing and commercializing meaningful products
that address unmet medical needs. The company has a diverse
portfolio of products and product candidates, with a focus in the
areas of sleep and hematology/oncology. In these areas, Jazz
Pharmaceuticals markets Xyrem® (sodium oxybate) oral solution,
Erwinaze® (asparaginase Erwinia chrysanthemi) and Defitelio®
(defibrotide sodium) in the U.S. and markets Erwinase® and
Defitelio® (defibrotide) in countries outside the U.S. For more
information, please visit www.jazzpharmaceuticals.com.
"Safe Harbor" Statement under the Private Securities
Litigation Reform Act of 1995
This press release contains
forward-looking statements, including, but not limited to,
statements related to the expected timing of reporting top-line
results from the company's Phase 3 OSA studies, and other
statements that are not historical facts. These
forward-looking statements are based on the company's current
plans, objectives, estimates, expectations and intentions, and
inherently involve significant risks and uncertainties.
Actual results and the timing of events could differ materially
from those anticipated in such forward-looking statements as a
result of these risks and uncertainties, which include, without
limitation, risks and uncertainties associated with the difficulty
and uncertainty of pharmaceutical product development and the
uncertainty of clinical success and other risks and uncertainties
affecting the company and its development programs, including those
described from time to time under the caption "Risk Factors" and
elsewhere in Jazz Pharmaceuticals plc's Securities and Exchange
Commission filings and reports (Commission File No. 001-33500),
including the company's Quarterly Report on Form 10-Q for the
quarter ended June 30, 2016 and
future filings and reports by the company. Other risks and
uncertainties of which the company is not currently aware may also
affect the company's forward-looking statements and may cause
actual results and the timing of events to differ materially from
those anticipated. The forward-looking statements herein are
made only as of the date hereof or as of the dates indicated in the
forward-looking statements, even if they are subsequently made
available by the company on its website or otherwise. The
company undertakes no obligation to update or supplement any
forward-looking statements to reflect actual results, new
information, future events, changes in its expectations or other
circumstances that exist after the date as of which the
forward-looking statements were made.
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SOURCE Jazz Pharmaceuticals plc