65-center trial of sodium oxybate for fibromyalgia pain completed; second phase III trial still recruiting in US and UK

“We anticipate releasing primary efficacy and safety data from the first Phase III clinical trial on schedule in the fourth quarter of this year, and we continue to plan for submission of a New Drug Application to the FDA by the end of 2009." Samuel Saks, MD

Jazz Pharmaceuticals, Inc. announced on Sept 11 that the final patient has completed participation in the first Phase III pivotal clinical trial of JZP-6 [sodium oxybate, brand name Zyrem®] for the treatment of fibromyalgia.

The JZP-6 Phase III clinical trial program includes two randomized, double blind, placebo-controlled studies. The first study enrolled 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 [UK] (see description at http://www.clinicaltrials.gov).

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.

"Completion of the final patient's participation in this trial is a key milestone in the JZP-6 program," said Samuel Saks, MD, Chief Executive Officer. "The trial results remain blinded to the company, investigators, and patients. We will remain blinded as we conduct analysis of the extensive data set generated by this study. We anticipate releasing primary efficacy and safety data from the first Phase III clinical trial on schedule in the fourth quarter of this year, and we continue to plan for submission of a New Drug Application to the FDA by the end of 2009."

"We appreciate the dedication of the patients, clinical investigators and Jazz Pharmaceuticals employees who are taking part in this important program," Dr. Saks continued.

The JZP-6 clinical program also includes an open-label continuation trial [without placebo comparison] to provide long-term safety data. Enrollment in this trial is ongoing … open to patients who complete either of the two pivotal Phase III trials.

Sodium oxybate is the active ingredient in Xyrem®, a Jazz Pharmaceuticals product 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 has not been approved for the treatment of Fibromyalgia.

Source: Jazz Pharmaceuticals, Inc.

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