DUBLIN, March 15, 2017 /PRNewswire/ -- Jazz
Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the first
patient has been enrolled in a Phase 3 clinical study evaluating
JZP-258, an investigational oxybate product candidate with 90
percent less sodium content than Xyrem® (sodium oxybate) oral
solution, as a potential treatment for cataplexy and excessive
daytime sleepiness (EDS) in adult narcolepsy patients. The
clinical study will be conducted across approximately 60 centers in
the European Union and the United
States.
"We believe that reducing sodium intake in narcolepsy patients
is a clinically meaningful goal as patients with narcolepsy are at
risk for high sodium intake-related consequences, including
hypertension and other cardiovascular diseases," said Karen Smith, M.D., Ph.D., global head of
research and development and chief medical officer of Jazz
Pharmaceuticals. "The initiation of patient enrollment in this
study reinforces our commitment to the narcolepsy community and is
an important step in our efforts to provide patients with
potentially improved therapeutic options to treat their
narcolepsy."
The Phase 3 study is a double-blind, placebo-controlled,
randomized-withdrawal, multicenter study evaluating the efficacy
and safety of JZP-258 for the treatment of cataplexy and EDS in
adult patients with narcolepsy (ClinicalTrials.gov identifier:
NCT03030599). The study is expected to enroll approximately 185
patients in order to randomize approximately 130 patients.
About JZP-258
JZP-258 is an investigational product
candidate being evaluated in adult patients for the treatment of
cataplexy and EDS in narcolepsy. JZP-258 was evaluated in a
Phase 1 clinical study in 60 healthy adults and exhibited a safety
profile similar to Xyrem.1 Xyrem is currently
approved for narcolepsy with cataplexy and EDS and, at the highest
approved dose of 9 grams per night, contains 1,640 mg of
sodium. JZP-258 is an oral solution that contains a mixture
of oxybate salts, resulting in 90% less sodium content than
Xyrem.
About Narcolepsy
Narcolepsy is a chronic sleep
disorder that involves the brain's inability to regulate sleep-wake
cycles normally. It affects an estimated 1 in 2,000 people in
the United States, with symptoms
typically appearing in early adulthood. It is estimated that
50 percent or more patients with narcolepsy have not been
diagnosed. Studies have shown it may take 10 years or more
for people with narcolepsy to receive a correct diagnosis.
Beyond the challenges with narcolepsy diagnosis, scientific
publications report that individuals with narcolepsy have an
increased frequency of multiple organic diseases, including heart
disease, hypertension, and hypercholesterolemia compared to matched
controls in the general population.2,3
Dietary Sodium Intake Recommendations
High consumption
of sodium in diets has also been strongly linked to the development
of high blood pressure and the risk of heart
disease.4 The American Heart Association
recommends that an ideal diet be limited to no more than 1,500 mg
of sodium per day for most adults.5
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 JZP-258 as a potential
treatment for cataplexy and excessive daytime sleepiness (EDS) in
adult patients with narcolepsy 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: pharmaceutical product development and clinical success
thereof; and the regulatory approval process; 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 Annual Report on Form 10-K for
the year ended December 31, 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.
References:
1. Data from Phase 1 clinical trial on file.
2. Ohayon MM. Narcolepsy is complicated by high medical and
psychiatric comorbidities: a comparison with the general
population. Sleep Med. 2013;14:488-492.
3. Jennum P, Ibsen R, Knudsen S, Kjellberg J. Comorbidity and
mortality of narcolepsy: a controlled retro- and prospective
national study. Sleep. 2013;36:835-840.
4. IOM (2013). "Sodium Intake in Populations: Assessment of
Evidence," Washington DC. The
National Academies Press.
5. American Heart Association link downloaded March14, 2017.
http://www.heart.org/HEARTORG/HealthyLiving/HealthyEating/Nutrition/Sodium-and-Salt_UCM_303290_Article.jsp#.WMLYem8rLIU
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SOURCE Jazz Pharmaceuticals plc