Data Suggest Sodium Oxybate Significantly Improves Pain and the Core Symptoms of Fibromyalgia

PALO ALTO, Calif., June 15 CA-Jazz-Pharmaceutica
PALO ALTO, Calif., June 15 /PRNewswire-FirstCall/ -- Jazz Pharmaceuticals' (Nasdaq: JAZZ) sodium oxybate (JZP-6) demonstrated statistically significant and clinically meaningful improvement in pain and the core symptoms associated with fibromyalgia, according to Phase III data presented last week at the 2009 Associated Professional Sleep Societies meeting in Seattle, WA. These data have not been evaluated by the FDA or other regulatory authorities for use of sodium oxybate in the treatment of fibromyalgia.

Widespread chronic pain is the hallmark of fibromyalgia, but the vast majority of patients are also affected by a broader constellation of symptoms, including fatigue, sleep disturbances, cognitive dysfunction, and impaired physical function.

"The data showed that sodium oxybate improves the key symptoms of fibromyalgia: pain, fatigue, and sleep disturbances," said Dr. Todd Swick, one of the study's investigators and Medical Director of the Houston Sleep Center and Assistant Clinical Professor of Neurology at the University of Texas-Houston School of Medicine. "Millions of people are diagnosed with fibromyalgia and there is a continuing unmet need for therapies that address the constellation of symptoms that can have a significant impact on patients' quality of life."

The 14-week randomized, double-blind, placebo-controlled study included 548 adult patients with fibromyalgia randomized to one of three treatment arms: sodium oxybate 4.5 g/night, sodium oxybate 6 g/night or placebo. The primary outcome measure was the proportion of patients who achieved at least 30% reduction in pain from baseline to endpoint based on the Pain Visual Analog Scale (VAS).

At three months, 54.2% (p<0.001) of patients treated with sodium oxybate 4.5 g/night and 58.5% (p<0.001) of patients treated with sodium oxybate 6 g/night showed significantly greater reduction in pain as measured by at least a 30% improvement in baseline pain VAS score, compared with 35.2% of patients taking placebo using Last Observation Carried Forward analysis.

Additional Data Highlights

• Patients treated with sodium oxybate 4.5 g/night and 6g/night showed significant reductions in fatigue as early as Week 1 after dosing compared with placebo as measured by the Fatigue VAS (p<0.001). These differences were maintained throughout the 14 weeks of the study (p less than or equal to 0.009).
• Patients taking sodium oxybate 4.5 g/night and 6g/night showed significant improvement in sleep patterns compared to placebo as measured by the Jenkins Sleep Scale (p<0.001).
• Statistically significant improvements in mean scores on the Fibromyalgia Impact Questionnaire, a measure of daily function, and on Patient Global Impression of Change were seen in patients receiving sodium oxybate compared to placebo.
• Sodium oxybate was generally well tolerated, with the majority of adverse events reported being mild to moderate in nature. Adverse events were similar to those seen in previous sodium oxybate experience.
• In this study, the most common adverse events, with incidence greater than or equal to 5% and at least twice the rate of placebo, were headache, nausea, dizziness, vomiting, diarrhea, anxiety, and sinusitis.
  

Additional details on the data presented at the 2009 APSS can be found at http://www.journalsleep.org/PDF/AbstractBook2009.pdf (abstract 0984, p.354).

Development Plans
Jazz Pharmaceuticals has completed its second Phase III clinical trial of JZP-6 and expects to announce top-line results from this study around mid-2009. Assuming positive results for 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. UCB anticipates filing in the EU shortly after. UCB has the exclusive marketing and distribution rights to sodium oxybate for fibromyalgia in Europe and some other countries outside North America and will manage registrations accordingly.

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. Additional safety information for Xyrem, including black box warnings, can be found in the full prescribing information at http://www.xyrem.com/prescribing-information.php.

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 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.