UPDATE 1-Jazz says fibromyalgia drug meets main goal of study

Thu Nov 20, 2008 10:44pm GMT
 
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Nov 20 (Reuters) - Jazz Pharmaceuticals Inc (JAZZ.O) said its experimental treatment for fibromyalgia, a chronic pain syndrome, met the main goal of reducing pain and fatigue in the first of two late-stage trials.

In the study that enrolled 548 patients, the company said sodium oxybate, or JZP-6, reduced at least 30 percent pain or more in both the 4.5 gram and 6 gram dosages compared to a dummy drug and also improved daily function in patients with fibromyalgia.

The company plans to file a new drug application with U.S. health regulators by the end of 2009.

Sodium oxybate is already being marketed under the brand Xyrem in the United States as an oral solution for the treatment of narcolepsy, a condition marked by excessive daytime sleepiness, impaired vision and muscle weakness.

Belgian pharmaceutical group UCB (UCB.BR) has the exclusive marketing and distribution rights to Xyrem for fibromyalgia in Europe.

Shares of Jazz Pharmaceuticals closed at $1.19 Thursday on Nasdaq. (Reporting by Vidya L Nathan in Bangalore; Editing by Deepak Kannan0

 
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