Jazz Pharmaceuticals, Inc. Completes Enrollment in Second of Two Phase III Clinical Trials of Sodium Oxybate to Treat Fi...( PALO ALTO Calif. Jan. 13 /- Jazz ...),Health

PALO ALTO, Calif., Jan. 13 /PRNewswire-FirstCall/ -- Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) today announced completion of enrollment in the second of two Phase III pivotal clinical trials of JZP-6 (sodium oxybate) for the treatment of fibromyalgia.

"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," said Samuel Saks, M.D., Chief Executive Officer.

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 U.S. and Europe.

Jazz Pharmaceuticals anticipates submitting a New Drug Application for sodium oxybate to the U.S. Food and Drug Administration 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.

About Sodium Oxybate

Sodium oxybate is the sodium salt form of gamma-hydroxybutyrate, an endogenous neurotransmitter and metabolite of GABA. While the precise mechanism of action is unknown, the effects may be mediated in part through interaction with GABA(B) and GHB receptors. Sodium oxybate is the active ingredient in XYREM(R), approved by the FDA for the treatment of excessive daytime sleepiness (EDS) and cataplexy (the sudden loss of muscle tone) in adult patients with narcolepsy. The American Academy of Sleep Medicine recommends sodium oxybate as a standard of care for the U.S. Food and Drug Administration-approved indications. It is also approved by the European Medical Evaluation Agency (EMEA) for the treatment o
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