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news.US-based specialty pharmaceutical company Jazz Pharmaceuticals has announced that the final patient has completed participation in the first Phase III pivotal clinical trial of JZP-6 for the treatment of fibromyalgia.
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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 US.
The second Phase III study is enrolling patients at sites in the US and Europe. The primary endpoint for both studies is the change from baseline in pain based on the pain visual analog scale, which the FDA and the European Medicines Agency have indicated is the appropriate primary endpoint.
The JZP-6 clinical program also includes an open-label continuation trial to provide long-term safety data. Enrollment in this trial is ongoing, and the trial is open to patients who complete either of the two pivotal Phase III trials.
Samuel Saks, CEO of Jazz Pharmaceuticals, said: “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.”