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Jazz Pharmaceuticals, Inc. Completes Enrollment in First of Two Phase III Clinical Trials of Sodium Oxybate to Treat Fibromyalgia
Date:6/2/2008

PALO ALTO, Calif., June 2 /PRNewswire-FirstCall/ -- Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) today announced completion of enrollment in the first of two Phase III pivotal clinical trials of JZP-6 (sodium oxybate) for the treatment of fibromyalgia.

"Completion of enrollment in this trial is a key milestone in the JZP-6 program. We expect to report top line results from this trial in the fourth quarter of 2008," 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 has completed enrollment of 550 fibromyalgia patients at 65 centers in the U.S. The second Phase III study is enrolling patients at sites in the U.S. and Europe. The primary endpoint for both studies is the change from baseline in pain based on the pain visual analog scale, which the U.S. Food and Drug Administration (FDA) and the European Medicines Agency have indicated is the appropriate primary endpoint.

In a Phase II clinical trial completed in 2005, fibromyalgia patients taking sodium oxybate, the active ingredient in JZP-6, achieved a statistically significant improvement in pain compared to placebo based on the pain visual analog scale. These results need to be confirmed in the ongoing Phase III clinical trials.

The JZP-6 clinical program also includes an open-label continuation trial to provide long-term safety data. Enrollment in this trial is underway, and the trial is open to patients who complete one of the two pivotal Phase III trials.

Sodium oxybate is approved by the FDA for the treatment of excessive daytime sleepiness and cataplexy (the sudden loss of muscle tone) in patients with narcolepsy. Sodium oxybate
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SOURCE Jazz Pharmaceuticals, Inc.
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