FM & CFIDS INFORMATION - WELLNESS TRAIN: Final Patient Completes Phase III Trial for Fibromyalgia Treatment

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Final Patient Completes Phase III Trial for Fibromyalgia Treatment

Posted by MERM on 1/26/2009, 9:04 am

Final Patient Completes Phase III Trial for Fibromyalgia Treatment

The first Phase III pivotal clinical trial from Jazz Pharmaceuticals in studying JZP-6 for the treatment of fibromyalgia has been completed.

The program includes two randomized, double-blind, placebo-controlled studies. The first one enrolled 550 patients at 65 centers in the U.S.; the second study is enrolling patients at sites in the U.S. and Europe. The primary endpoint for both studies is change in pain.

The company said it remains blinded to the trial results but will release its primary efficacy and safety data in the fourth quarter of the year. It plans to submit an NDA to the FDA by the end of 2009. sourcewebmdmermwellnesstrainresearchteam!M!

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Final Patient Completes Phase III Trial for Fibromyalgia Treatment - MERM 1/26/2009, 9:04 am
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--Previous Message-- : Final Patient Completes Phase III Trial for : Fibromyalgia Treatment : : The first Phase III pivotal clinical trial : from Jazz Pharmaceuticals in studying JZP-6 : for the treatment of fibromyalgia has been : completed. : : The program includes two randomized, : double-blind, placebo-controlled studies. : The first one enrolled 550 patients at 65 : centers in the U.S.; the second study is : enrolling patients at sites in the U.S. and : Europe. The primary endpoint for both : studies is change in pain. : : The company said it remains blinded to the : trial results but will release its primary : efficacy and safety data in the fourth : quarter of the year. It plans to submit an : NDA to the FDA by the end of 2009. : sourcewebmdmermwellnesstrainresearchteam!M! : :

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