Positive Prelimiary Results for Potential Fibromyalgia Treatment

NEWSBRIEF: Jazz Pharmaceuticals and UCB announce positive preliminary results in the first of two Phase III clinical trials of JZP-6 (sodium oxybate) for treating fibromyalgia. Sodium oxybate is the active ingredient in the narcolopsy drug Xyrem.

The double-blind, placebo-controlled study suggested that the drug significantly decreased pain and fatigue, and improved daily function in people with fibromyalgia. The most common side effects were:

• Headache
• Nausea
• Dizziness
• Vomiting
• Diarrhea
• Anxiety
• Sinusitis

The company says the majority of side effects were mild to moderate and that the drug is generally well tolerated.

Jazz Pharmaceuticals anticipates submitting a New Drug Application for sodium oxybate to the U.S. FDA by the end of 2009, meaning the drug could be on the market before 2011. In Europe, UCB anticipates filing shortly after Jazz files its NDA.

Related Content: Drugs as Fibromyalgia Treatments