Navigation Links
Jazz Pharmaceuticals, Inc. Completes Enrollment in First of Two Phase III Clinical Trials of Sodium Oxybate to Treat Fibromyalgia
Date:6/2/2008

PALO ALTO, Calif., June 2 /PRNewswire-FirstCall/ -- Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) today announced completion of enrollment in the first of two Phase III pivotal clinical trials of JZP-6 (sodium oxybate) for the treatment of fibromyalgia.

"Completion of enrollment in this trial is a key milestone in the JZP-6 program. We expect to report top line results from this trial in the fourth quarter of 2008," 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 has completed enrollment of 550 fibromyalgia patients at 65 centers in the U.S. The second Phase III study is enrolling patients at sites in the U.S. and Europe. The primary endpoint for both studies is the 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 have indicated is the appropriate primary endpoint.

In a Phase II clinical trial completed in 2005, fibromyalgia patients taking sodium oxybate, the active ingredient in JZP-6, achieved a statistically significant improvement in pain compared to placebo based on the pain visual analog scale. These results need to be confirmed in the ongoing Phase III clinical trials.

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

Sodium oxybate is approved by the FDA for the treatment of excessive daytime sleepiness and cataplexy (the sudden loss of muscle tone) in patients with narcolepsy. Sodium oxybate has not been approved for the treatment of fibromyalgia.

About Fibromyalgia

Fibromyalgia is a chronic pain syndrome defined by widespread pain lasting at 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. In addition to pain, fibromyalgia patients often suffer from a combination of muscle stiffness, fatigue, disturbed sleep, restless legs syndrome and impaired memory and concentration. Although physicians do not understand the cause of fibromyalgia, it may be triggered by physical trauma, emotional stress or infection. The criteria established by the American College of Rheumatology for the classification of fibromyalgia require the application of pressure at 18 different points on the body and measurement of pain induced by such pressure. If at least 11 of the 18 points are painful and have been painful for three months, the patient is diagnosed with fibromyalgia.

About Jazz Pharmaceuticals, Inc.

Jazz Pharmaceuticals is a specialty pharmaceutical company focused on identifying, developing and commercializing innovative products to meet unmet medical needs in neurology and psychiatry. For further information see http://www.JazzPharmaceuticals.com.

"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995

This press release contains forward-looking statements, including, but not limited to, statements related to the continued development of Jazz Pharmaceuticals' JZP-6 product candidate and the timing of clinical study results. These forward-looking statements are based on the company's current expectations and inherently involve significant risks and uncertainties. Jazz Pharmaceuticals' actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to the clinical trials of Jazz Pharmaceuticals' JZP-6 product candidate, including the risk that clinical trial results may require Jazz Pharmaceuticals to discontinue its development, and risks related to our reliance on third parties to conduct the clinical trials for our product candidates. These and other risk factors are discussed under "Risk Factors" in the Quarterly Report on Form 10-Q for the quarter ended March 31, 2008 filed by Jazz Pharmaceuticals with the Securities and Exchange Commission on May 15, 2008. Jazz Pharmaceuticals undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations.


'/>"/>
SOURCE Jazz Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Arena Pharmaceuticals, Inc. Announces Initiation of Phase 1 Clinical Trial of Drug Candidate Under Partnership with Taisho Pharmaceutical Co., Ltd.
2. Alseres Pharmaceuticals, Inc. to Address a Congressional Briefing on Paralysis Research and the Spinal Cord Injury Community at Working 2 Walk in Washington, DC, April 13-15, 2008
3. Lotus Pharmaceuticals, Inc. Achieves Significant Milestones in the Development of Isosorbide Mononitrate Sustained Release Tablets
4. Jazz Pharmaceuticals, Inc. Announces Receipt of FDA Orphan Drug Designation for Recurrent Acute Repetitive Seizures Product Candidate
5. Solvay Pharmaceuticals, Inc. Responds to Advisory Committee Recommendation for Further Study of Tedisamil to Treat Atrial Fibrillation
6. Keryx Biopharmaceuticals, Inc. Announces Phase 1 and Phase 2 Data on KRX-0401 (Perifosine) in Patients with Relapsed/Refractory Multiple Myeloma at 49th Annual Meeting of American Society of Hematology
7. Quark Pharmaceuticals, Inc. Announces First Systemic siRNA Dosing in Humans
8. Keryx Biopharmaceuticals, Inc. Announces Positive Preliminary Phase 2 Data on KRX-0401 in Patients with Chemo-Insensitive Rare Sarcoma
9. Aegerion Pharmaceuticals, Inc. Presents Final Results of Phase II Clinical Trials for AEGR-733 at Drugs Affecting Lipid Metabolism (DALM) 2007 Conference
10. Symbollon Pharmaceuticals, Inc. Evaluates the Clinical Effects of IoGen(TM) on Fibrocystic Breast Disease
11. Sucampo Pharmaceuticals, Inc. Begins Pivotal Phase III Studies of Oral Lubiprostone to Treat Opioid-Induced Bowel Dysfunction (OBD)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/23/2016)... Non-invasive diagnostic test realizes the potential of ... be presented at Yissum’s booth, at IATI-BIOMED 2016 conference  ... the Hebrew University of Jerusalem announced today it ... MKI, the technology investment arm of Morris Kahn , ... early detection of multiple diseases by analyzing circulating DNA ...
(Date:5/23/2016)... May 23, 2016 Gamida Cell, ... treatment of cancer and orphan genetic diseases, announced today ... $4.4 million from the Israel Innovation Authority (formerly the ... of Economy and Industry. The mission of the Israel ... various industries, including science and technology, while stimulating economic ...
(Date:5/23/2016)... Conn. , May 23, 2016   ... has entered into an agreement with Egalet Corporation ... patent claims. As part of the agreement the ... and will enable all three companies to develop ... properties. "This agreement reflects the commitment ...
Breaking Medicine Technology:
(Date:5/25/2016)... ... May 25, 2016 , ... Researchers from SUNY State College of Optometry won ... on visual evoked potential and human attention. The article, VEP and Human Attention: ... NOVA™ ERG and VEP Vision Testing System (Diopsys, Inc., Pine Brook, NJ) to ...
(Date:5/25/2016)... TX (PRWEB) , ... May 25, 2016 , ... ... the United States, named Dr. Anh Tat Nguyen, as the Medical Director of its ... the facility Medical Director of our new DeSoto location,” said Dr. James M. Muzzarelli, ...
(Date:5/25/2016)... New Jersey (PRWEB) , ... May 25, 2016 , ... ... specialized technology firm will be selling the device branded as Stern’s Real Time ... is geared to bedbugs to the hotel and motel industry, colleges for use in ...
(Date:5/24/2016)... (PRWEB) , ... May 24, 2016 , ... According to ... that a group of people randomly assigned to reduce the amount of calories they ... 12 percent drop in body weight enjoyed better sleep, improved quality of life, and ...
(Date:5/24/2016)... ... 24, 2016 , ... BTC Media, a leading digital currency ... to be held in Nashville, Tennessee on September 7, 2016. , The conference ... the event will host teams from around the world, competing to build the ...
Breaking Medicine News(10 mins):