DUBLIN, Nov. 28, 2016 /PRNewswire/ -- Jazz
Pharmaceuticals plc (Nasdaq: JAZZ) today 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,"
said Karen Smith, M.D., Ph.D.,
global head of research and development and chief medical officer
of Jazz Pharmaceuticals. "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.
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 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.
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
and narcolepsy 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 September
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