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news.Jazz Pharmaceuticals has completed enrollment in the first of two Phase III pivotal clinical trials 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 has completed enrollment of 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 underway, and the trial is open to patients who complete one of the two pivotal Phase III trials.
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.
Samuel Saks, CEO of Jazz Pharmaceuticals, said: “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.”