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Jazz Pharmaceuticals and UCB Announce Second Phase III Study of Sodium Oxybate in Patients With Fibromyalgia Meets Primary Endpoints
Date:6/24/2009

Preliminary top-line results of second Phase III study show highly significant decreases in pain and fatigue and improved daily function in fibromyalgia patients and confirm results from the first Phase III study

PALO ALTO, Calif., and BRUSSELS, June 24 /PRNewswire-FirstCall/ -- press release, regulated information -- Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) and UCB (Euronext Brussels: UCB) announced today positive preliminary top-line results from the second of two Phase III clinical trials of sodium oxybate (JZP-6) for the treatment of fibromyalgia. Confirming the positive results from the first Phase III study, this international, placebo-controlled trial of sodium oxybate to treat fibromyalgia achieved its key endpoints. As in the first randomized, double-blind fibromyalgia study, sodium oxybate significantly decreased pain and fatigue and improved daily function and patient global impression of change. Sodium oxybate has not been evaluated by regulators for the treatment of fibromyalgia and is not approved for this use.

"Fibromyalgia is a chronic illness, characterized by widespread pain, unrefreshing sleep, chronic fatigue, and psychological distress," said I. Jon Russell, M.D., Ph.D., lead investigator in the first Phase III study 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. "Sodium oxybate has shown a positive effect on a number of the symptoms of fibromyalgia, and thus could have a significant impact on patients' quality of life."

The second 14-week Phase III trial, conducted in the United States and seven European countries, included 573 adult patients with fibromyalgia randomized to one of three treatment arms: sodium oxybate 4.5 g/nigh
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SOURCE Jazz Pharmaceuticals, Inc.; UCB
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