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Jazz Pharmaceuticals and UCB Announce Positive Phase III Results for Sodium Oxybate (JZP-6) in Fibromyalgia
Date:11/20/2008 

    PRELIMINARY TOP LINE RESULTS OF FIRST PHASE III TRIAL SHOW SIGNIFICANT
     DECREASES IN PAIN AND FATIGUE, AND IMPROVEMENT IN DAILY FUNCTION, IN
                            FIBROMYALGIA PATIENTS

PALO ALTO, Calif., and BRUSSELS, Belgium, Nov. 20 /PRNewswire-FirstCall/ -- Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) and UCB (Euronext Brussels: UCB) announced today positive preliminary top-line results from the first of two Phase III pivotal clinical trials of sodium oxybate (JZP-6) for the treatment of fibromyalgia. The randomized, double-blind, placebo-controlled study achieved its primary endpoints, demonstrating that sodium oxybate significantly decreased pain and fatigue, and improved daily function, in patients with fibromyalgia.

"There is a significant unmet need in diagnosing and treating millions of patients with fibromyalgia. Potential new treatments that address the various symptoms can have a significant impact on patients' quality of life," said I. Jon Russell, M.D., Ph.D., the study's lead investigator and Associate Professor of Medicine, Division of Clinical Immunology and Rheumatology, and Director, University Clinical Research Center, University of Texas Health Science Center at San Antonio.

The 14-week 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, viewed by both U.S. and EU regulatory authorities as a clinically meaningful endpoint, was the proportion of patients who achieved at least 30 percent reduction in pain from baseline to endpoint based on the Pain Visual Analog Scale (VAS). In the EU it is also considered that Fibromyalgia Impact Questionnaire (FIQ) data is equally relevant. FIQ data are considered supportive data by U.S. regula
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SOURCE Jazz Pharmaceuticals, Inc.
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