PALO ALTO, Calif., June 2 Jazz Pharmaceuticals,Inc. (Nasdaq: JAZZ) today announced completion of enrollment in the first oftwo Phase III pivotal clinical trials of JZP-6 (sodium oxybate) for thetreatment of fibromyalgia.
"Completion of enrollment in this trial is a key milestone in the JZP-6program. We expect to report top line results from this trial in the fourthquarter of 2008," said Samuel Saks, M.D., Chief Executive Officer.
The JZP-6 Phase III clinical trial program includes two randomized, doubleblind, placebo-controlled studies. The first study has completed enrollmentof 550 fibromyalgia patients at 65 centers in the U.S. The second Phase IIIstudy is enrolling patients at sites in the U.S. and Europe. The primaryendpoint for both studies is the change from baseline in pain based on thepain visual analog scale, which the U.S. Food and Drug Administration (FDA)and the European Medicines Agency have indicated is the appropriate primaryendpoint.
In a Phase II clinical trial completed in 2005, fibromyalgia patientstaking sodium oxybate, the active ingredient in JZP-6, achieved astatistically significant improvement in pain compared to placebo based on thepain visual analog scale. These results need to be confirmed in the ongoingPhase III clinical trials.
The JZP-6 clinical program also includes an open-label continuation trialto provide long-term safety data. Enrollment in this trial is underway, andthe trial is open to patients who complete one of the two pivotal Phase IIItrials.
Sodium oxybate is approved by the FDA for the treatment of excessivedaytime sleepiness and cataplexy (the sudden loss of muscle tone) in patientswith narcolepsy. Sodium oxybate has not been approved for the treatment offibromyalgia.
Fibromyalgia is a chronic pain syndrome defined by widespread pain lastingat least three months. According to the American College of Rheumatology,between two and four percent of the U.S. population suffers from fibromyalgia.Fibromyalgia is believed to be a central nervous system condition. Inaddition to pain, fibromyalgia patients often suffer from a combination ofmuscle stiffness, fatigue, disturbed sleep, restless legs syndrome andimpaired memory and concentration. Although physicians do not understand thecause of fibromyalgia, it may be triggered by physical trauma, emotionalstress or infection. The criteria established by the American College ofRheumatology for the classification of fibromyalgia require the application ofpressure at 18 different points on the body and measurement of pain induced bysuch pressure. If at least 11 of the 18 points are painful and have beenpainful for three months, the patient is diagnosed with fibromyalgia.
About Jazz Pharmaceuticals, Inc.
Jazz Pharmaceuticals is a specialty pharmaceutical company focused onidentifying, developing and commercializing innovative products to meet unmetmedical needs in neurology and psychiatry. For further information seehttp://www.JazzPharmaceuticals.com.
"Safe Harbor" Statement under the Private Securities Litigation Reform Actof 1995
This press release contains forward-looking statements, including, but notlimited to, statements related to the continued development of JazzPharmaceuticals' JZP-6 product candidate and the timing of clinical studyresults. These forward-looking statements are based on the company's currentexpectations and inherently involve significant risks and uncertainties. JazzPharmaceuticals' actual results and the timing of events could differmaterially from those anticipated in such forward looking statements as aresult of these risks and uncertainties, which include, without limitation,risks related to the clinical trials of Jazz Pharmaceuticals' JZP-6 productcandidate, including the risk that clinical trial results may require JazzPharmaceutica