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
'/>"/>

SOURCE Jazz Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3

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:10/22/2014)... SHANGHAI , Oct. 22, 2014 /PRNewswire/ ... FMI ) and WuXi PharmaTech (Cayman) Inc. (NYSE: ... Foundation Medicine,s comprehensive genomic profiling to biopharmaceutical companies conducting ... Under the terms of the collaboration, Foundation ... laboratory component of Foundation Medicine,s FoundationOne® assay at the ...
(Date:10/20/2014)... , Oct. 20, 2014  Luoxis Diagnostics, Inc., ... AMPE), today announced that its academic collaborators will ... research potential for its novel RedoxSYS Diagnostic System, ... in the body in response to injury or ... ORP as a clinical marker will be presented ...
(Date:10/20/2014)...  AnaptysBio, Inc., a leader in the discovery ... appointment of Marco Londei , M.D. as ... preclinical and clinical development of AnaptysBio,s proprietary antibody ... welcome Dr. Londei to AnaptysBio,s executive leadership team," ... Executive Officer of AnaptysBio. "Dr. Londei,s extensive expertise ...
Breaking Medicine Technology:Foundation Medicine and WuXi PharmaTech Announce Strategic Collaboration to Offer Best-in-Class Comprehensive Genomic Profiling in China 2Foundation Medicine and WuXi PharmaTech Announce Strategic Collaboration to Offer Best-in-Class Comprehensive Genomic Profiling in China 3Foundation Medicine and WuXi PharmaTech Announce Strategic Collaboration to Offer Best-in-Class Comprehensive Genomic Profiling in China 4Foundation Medicine and WuXi PharmaTech Announce Strategic Collaboration to Offer Best-in-Class Comprehensive Genomic Profiling in China 5Luoxis to Highlight RedoxSYS at Two Upcoming Scientific Conferences 2Luoxis to Highlight RedoxSYS at Two Upcoming Scientific Conferences 3Luoxis to Highlight RedoxSYS at Two Upcoming Scientific Conferences 4Luoxis to Highlight RedoxSYS at Two Upcoming Scientific Conferences 5AnaptysBio Appoints Dr. Marco Londei to Newly Created Chief Development Officer Position Clinical Immunologist to Lead AnaptysBio's Pipeline Advancement 2
(Date:10/22/2014)... October 22, 2014 Isabel Healthcare ... Allied Health Professions (ASAHP) Conference on October 22-24 in ... will participate in a panel discussion on Technology in ... Isabel Healthcare provides a diagnostic decision support tool and ... diagnosis skills of students and clinical learners. The Isabel ...
(Date:10/22/2014)... (PRWEB) October 22, 2014 Shriners Hospitals ... that will change the current location of Shriners Hospitals ... South Limestone across from the University of Kentucky Albert ... state-of-the-art ambulatory care center, owned and operated by Shriners ... orthopaedic needs of children and their families well into ...
(Date:10/22/2014)... Pass, OR (PRWEB) October 22, 2014 ... Southern California’s fresh water supply runs dangerously low, Southern ... change. Southern Oregon’s rivers, despite the lowest mountain snow ... even in late summer and early autumn.* That was ... authors of the new book “Hiking Southern Oregon,” during ...
(Date:10/22/2014)... are only 24 hours in a day, that doesn’t seem to ... within their busy schedules for exercise and fitness. Fortunately, one does ... in shape. Here are five ways you can reach your fitness ... Your Commute , Consider riding a bike or taking the bus ... routine. If you must use your car to get to work, ...
(Date:10/22/2014)... Steven Reinberg HealthDay Reporter ... quickly add weight and length may be showing a genetic ... In adults, certain genes have been linked to increased body ... in fat and lean muscle, the researchers said. At ... taller. By ages 2 and 3, however, these genes were ...
Breaking Medicine News(10 mins):Health News:Isabel Healthcare to Participate in The Association of Schools of Allied Health Professions (ASAHP) 2014 Conference 2Health News:Shriners Hospitals for Children - Lexington Announces Plan to Build New $47 Million Facility 2Health News:Shriners Hospitals for Children - Lexington Announces Plan to Build New $47 Million Facility 3Health News:Southern Oregon Is West’s Most Drought Proof Fresh Water Region Say Hiking Guide Authors 2Health News:Southern Oregon Is West’s Most Drought Proof Fresh Water Region Say Hiking Guide Authors 3Health News:Southern Oregon Is West’s Most Drought Proof Fresh Water Region Say Hiking Guide Authors 4Health News:HealthGuideMD Presents Ways to Improve Your Exercise and Fitness 2Health News:Tall, Heavy 1-Year-Olds May Be at Risk for Obesity Later, Study Finds 2
... AS DR. KOSDON INSTALLS SEXIER SMILES, LINE-UP AND LAUGH WITH L.A. CONNECTION COMEDY THEATRE SO ... ... TUESDAY TEETH-TACULAR Who: Dr. Michael Kosdon and So Funny It Squirts! ... Where: 10545 Victory Blvd., North Hollywood, CA 91606, PHOTO OPS HUNDREDS OF ...
... Hendrix scheduled, DETROIT, March 26 The American Red ... Hero Awards,ceremony, presented by General Motors and OnStar by GM, ... from 6 p.m. to 9 p.m. Dennis W.,Archer, Red Cross ... help to honor the 11 Red Cross Heroes that hail ...
... reinvent excellence in global,healthcare delivery, WASHINGTON, March ... the world,s first integrated healthcare free zone,announced the ... of,their recently launched University Hospital. The University Hospital,s,objective ... life sciences research, post,graduate medical education, and secondary ...
... for the Concerns of General Dentists and Their Patients, ... Dentistry,s,(AGD) second annual advocacy conference, A Great Dentist Goes ... AGD constituent,leaders and member general dentists from 30 states ... these sophisticated skills to more,than 100 Congressional offices on ...
... Exposure in Light of New Evidence Showing the,Benefits ... March 26 Today, the Indoor,Tanning Association (ITA) ... rethink sun-tanning and criticizing,dermatologists and the sunscreen and ... The advertising blitz begins with a full-page ...
... March 26, 2008 Silver Spring, MD: Artemisinins in Malaria Therapy, ... Milhous, and Dr. (COL) Peter J. Weina (Division of Experimental ... overview of the historical use and recent developments in the ... the most prevalent scourges of mankind malaria. , WRAIR, ...
Cached Medicine News:Health News:American Red Cross Hero Awards to be Held March 27 2Health News:American Red Cross Hero Awards to be Held March 27 3Health News:Dubai Healthcare City Announces Appointment of James Kingsbury as Chief Executive Officer of University Hospital 2Health News:Dubai Healthcare City Announces Appointment of James Kingsbury as Chief Executive Officer of University Hospital 3Health News:Dubai Healthcare City Announces Appointment of James Kingsbury as Chief Executive Officer of University Hospital 4Health News:Dubai Healthcare City Announces Appointment of James Kingsbury as Chief Executive Officer of University Hospital 5Health News:AGD Advocacy Conference Connects General Dentists with Congress 2Health News:Indoor Tanning Association Launches Campaign Attacking Melanoma Hype 2Health News:WRAIR investigators pioneering work on an exciting new class of antimalarial compounds 2
ROB-NEL Catheters (100% Latex-Free)...
100% Silicone Foley Catheter Kits 2-Way...
Coude Foley Catheters (Latex) 2-Way Amber...
Silicone Elastomer-Coated Latex Foley Catheters 2-Way (Pediatric)...
Medicine Products: