BANGALORE (Reuters) – Jazz Pharmaceuticals Inc said the final patient had completed participation in the first late-stage trial of JZP-6 for the treatment of chronic pain syndrome, fibromyalgia, and it was on track to release study data in the fourth quarter.
The first study for JZP-6, also called sodium oxybate, enrolled 550 fibromyalgia patients at 65 centers in the United States. The second late stage study is enrolling patients at sites in the US and Europe.
“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 (U.S. Food and Drug Administration) by the end of 2009,” Chief Executive Officer Samuel Saks said in a statement.
Sodium oxybate is also the active ingredient in Jazz’s drug Xyrem, being sold as a treatment for the sleep disorder narcolepsy.
Shares of the drug company closed at $6.56 Wednesday on Nasdaq.
(Reporting by Aradhana Aravindan in Bangalore; Editing by Jarshad Kakkrakandy)