Final patient completes first Phase III Xyrem trial

Jazz Pharmaceuticals Inc. has announced that the final patient has completed the first Phase III trial of JZP-6 (sodium oxybate) as a treatment of Fibromyalgia Syndrome (Fibro).

The JZP-6 (sodium oxybate) Phase III clinical trial program includes two randomized, double blind, placebo-controlled studies.

The first study enrolled 550 Fibro patients at 65 centers in the U.S. The second Phase III study is enrolling patients at sites in the U.S. and Europe. Both studies are primarily looking for a change from baseline in pain based on the pain visual analog scale, which the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) have indicated is the appropriate primary endpoint.

Samuel Saks, M.D., Chief Executive Officer at Jazz Pharmaceuticals Inc. said:

"Completion of the final patient's participation in this trial is a key milestone in the JZP-6 program... The trial results remain blinded to the company, investigators, and patients. We will remain blinded as we conduct analysis of the extensive data set generated by this study. 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 by the end of 2009."

The JZP-6 clinical program also includes an open-label continuation trial to provide long-term safety data. Enrollment in this trial is ongoing, and the trial is open to patients who complete either of the two pivotal Phase III trials.

Sodium oxybate is the active ingredient in Xyrem(R), a Jazz Pharmaceuticals product approved by the FDA for the treatment of excessive daytime sleepiness and cataplexy (the sudden loss of muscle tone) in patients with narcolepsy.

Phase III trials are the final phase of trials needed before an application can be submitted to the US FDA for approval to be granted for a medication to be used specifically for the treatment of a condition. Two medications currently have FDA approval as treatments for Fibro: Lyrica (pregabalin) and Cymbalta (duloxetine). Neither drug is yet approved in the European Union as treatments specifically for Fibro, but these and other drugs will no doubt be applying for EMEA approval over the next few years.