The JZP-6 Phase III clinical trial program includes two randomized, double-blind, placebo-controlled studies. The first study was completed and positive top-line results were announced in November 2008. The second Phase III study has enrolled 575 patients at centers in the US and Europe.
Jazz Pharmaceuticals anticipates submitting a new drug application for JZP-6 (sodium oxybate) to the FDA by the end of 2009. UCB has the exclusive marketing and distribution rights to sodium oxybate for fibromyalgia in Europe and many other countries outside North America.
Samuel Saks, CEO of Jazz Pharmaceuticals, said: “Completion of enrollment in this second trial is a meaningful milestone in the JZP-6 program in fibromyalgia. We expect to report top-line results from this trial in mid-2009.”