PALO ALTO, Calif., June 9 /PRNewswire-FirstCall/ -- Jazz Pharmaceuticals,
Inc. (Nasdaq: JAZZ) announced today that data from the company's first Phase
III clinical trial of sodium oxybate (JZP-6) for the treatment of fibromyalgia
will be presented this week during the Associated Professional Sleep Societies
(APSS) 2009 Annual Meeting in Seattle, Washington and also during the European
League Against Rheumatism (EULAR) Congress in Copenhagen, Denmark.
Following are the details on each of these data presentations.
-- At APSS on June 10, 2009, Dr. Todd Swick will be presenting a poster
entitled "Impaired Sleep and Daytime Functioning at Baseline in
Subjects with Fibromyalgia: a 14-week Randomized, Double-blind,
Placebo-controlled Trial of Sodium Oxybate" in the 10:15 am-12:15 pm
poster session.
-- At APSS on June 11, 2009 at 9:00 am in Ballroom 6E, Dr. Swick will
also deliver an oral presentation entitled "Sodium Oxybate Improves
Pain, Fatigue, and Sleep in Fibromyalgia: Results from a 14-week
Randomized, Double-blind, Placebo-controlled Study."
-- At EULAR on June 12, 2009, in Room C2 from 5:30-7:00 pm, Dr. I. Jon
Russell will be presenting "Sodium Oxybate in the Treatment of
Fibromyalgia" at a UCB-sponsored Symposium entitled: "Fibromyalgia:
How Much More than Pain?" The symposium will be chaired by Dr. Ernest
Choy and also features Dr. Gilles Lavigne and Dr. Michael Spaeth as
speakers.
Jazz Pharmaceuticals has completed a second Phase III pivotal clinical
trial of JZP-6 and expects to announce top-line results from that study in
mid-2009. Assuming positive results in the second study, the company
anticipates submitting a New Drug Application for sodium oxybate for the
treatment of fibromyalgia to the U.S. Food and Drug Administration by the end
of 2009.
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 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 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.
About Fibromyalgia
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. For further information
please see http://www.JazzPharmaceuticals.com.
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 timing of results from the
second Phase III pivotal clinical trial and 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, risks related to the outcomes of the company's second
Phase III clinical study of sodium oxybate for the treatment of fibromyalgia
and the timing of the announcement of clinical results, and risks that a New
Drug Application may not be submitted, or may be delayed, and that sodium
oxybate for the treatment of fibromyalgia may not be approved for marketing by
regulatory authorities. These and other risk factors are discussed under "Risk
Factors" in the Quarterly Report on Form 10-Q for the quarter ended March 31,
2009 filed by Jazz Pharmaceuticals with the Securities and Exchange Commission
on May 7, 2009. 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.
Website: http://www.JazzPharmaceuticals.com
(C) 2009 Jazz Pharmaceuticals, Inc.
SOURCE Jazz Pharmaceuticals, Inc.
06/09/2009
CONTACT: Willie Quinn, Executive Director, Corporate Development of Jazz
Pharmaceuticals, Inc.,
+1-650-496-2800, investorinfo@jazzpharmaceuticals.com
/Web Site: http://www.jazzpharmaceuticals.com
(JAZZ)
