PALO ALTO, Calif., Jan. 13 /PRNewswire-FirstCall/ -- Jazz Pharmaceuticals,
Inc. (Nasdaq: JAZZ) today announced completion of enrollment in the second of
two Phase III pivotal clinical trials of JZP-6 (sodium oxybate) for the
treatment of fibromyalgia.
"Completion of enrollment in this second trial is a meaningful milestone
in the JZP-6 program in fibromyalgia. We expect to report top-line results
from this trial in mid-2009," said Samuel Saks, M.D., Chief Executive Officer.
The JZP-6 Phase III clinical trial program includes two randomized, double
blind, placebo-controlled studies. The first study was completed and positive
top-line results were announced in November 2008. The second Phase III study
has enrolled 575 patients at centers in the U.S. and Europe.
Jazz Pharmaceuticals anticipates submitting a New Drug Application for
sodium oxybate to the U.S. Food and Drug Administration by the end of 2009.
UCB has the exclusive marketing and distribution rights to sodium oxybate for
fibromyalgia in Europe and many other countries outside North America.
About Sodium Oxybate
Sodium oxybate is the sodium salt form of gamma-hydroxybutyrate, an
endogenous neurotransmitter and metabolite of GABA. While the precise
mechanism of action is unknown, the effects may be mediated in part through
interaction with GABA(B) and GHB receptors. Sodium oxybate is the active
ingredient in XYREM(R), approved by the FDA for the treatment of excessive
daytime sleepiness (EDS) and cataplexy (the sudden loss of muscle tone) in
adult patients with narcolepsy. The American Academy of Sleep Medicine
recommends sodium oxybate as a standard of care for the U.S. Food and Drug
Administration-approved indications. It is also approved by the European
Medical Evaluation Agency (EMEA) for the treatment of narcolepsy with
cataplexy in adult patients. Most commonly reported adverse drug reactions in
narcolepsy patients are dizziness, nausea and headaches. Sodium oxybate has
the potential to induce respiratory depression and neuropsychiatric events.
Sodium oxybate has not been evaluated by regulators for the treatment of
fibromyalgia and is not approved for this use.
Fibromyalgia, a chronic condition characterized by widespread pain,
affects 0.5% - 5% of adults worldwide. Fibromyalgia is believed to be a
central nervous system condition, resulting from neurological changes in how
the brain perceives and responds to pain. In addition to pain, the main
symptoms are fatigue, disturbed sleep and morning stiffness. The exact causes
of fibromyalgia are unknown. It may be triggered by physical trauma,
emotional stress, chronic pain or infection. Genetics, neurochemicals that
affect pain modulation, neurohormones and sleep physiology abnormalities are
thought to play a role. Research also has suggested a relationship between
sleep and pain. Fibromyalgia patients experience a high prevalence of sleep
problems, including a reduction in non-restorative or deep sleep.
About Jazz Pharmaceuticals, Inc.
Jazz Pharmaceuticals is a specialty pharmaceutical company that
identifies, develops and commercializes innovative treatments for important,
underserved markets in neurology and psychiatry. The Company has an
unwavering commitment to improving care for patients with serious psychiatric
and neurological conditions through innovative treatments and distinctive and
valuable programs for patients and physicians. For further information see
Jazz Pharmaceuticals "Safe Harbor" Statement under the Private Securities
Litigation Reform Act of 1995
This press release contains forward-looking statements related to the
development of Jazz Pharmaceuticals' sodium oxybate (JZP-6) product candidate
for the treatment of fibromyalgia, including the submission of a New Drug
Application to the FDA. These forward-looking statements are based on the
company's current expectations and inherently involve significant risks and
uncertainties. Jazz Pharmaceuticals' 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, the risk that clinical trial results may require Jazz
Pharmaceuticals to discontinue development of the sodium oxybate (JZP-6)
product candidate, risks related to Jazz Pharmaceuticals' reliance on third
parties to conduct the clinical trials for its product candidates, including
the second Phase III clinical trial of the sodium oxybate (JZP-6) product
candidate, and risks that regulatory filings may not be made, or may be
delayed, and that the sodium oxybate (JZP-6) product candidate for the
treatment of fibromyalgia may not be approved for marketing by regulatory
authorities, and risks related to Jazz Pharmaceuticals' need for additional
funding. These and other risk factors are discussed under "Risk Factors" in
the Quarterly Report on Form 10-Q for the quarter ended September 30, 2008
filed by Jazz Pharmaceuticals with the Securities and Exchange Commission on
November 14, 2008. Jazz Pharmaceuticals undertakes no duty or obligation to
update any forward-looking statements contained in this release as a result of
new information, future events or changes in its expectations.
SOURCE Jazz Pharmaceuticals, Inc.
Karen L. Bergman
both of BCC Partners for Jazz Pharmaceuticals, Inc.;
Senior Director of Licensing & Acquisitions of Jazz
Web site: http://www.jazzpharmaceuticals.com