Navigation Links
Jazz Pharmaceuticals, Inc. Announces Final Patient Has Completed Phase III Clinical Trial of Sodium Oxybate to Treat Fibromyalgia
Date:9/11/2008

PALO ALTO, Calif., Sept. 11 /PRNewswire-FirstCall/ -- Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) today announced that the final patient has completed participation in the first Phase III pivotal clinical trial of JZP-6 (sodium oxybate) for the treatment of fibromyalgia.

The JZP-6 Phase III clinical trial program includes two randomized, double blind, placebo-controlled studies. The first study enrolled 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.

"Completion of the final patient's participation in this trial is a key milestone in the JZP-6 program," said Samuel Saks, M.D., Chief Executive Officer. "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."

"We appreciate the dedication of the patients, clinical investigators and Jazz Pharmaceuticals employees who are taking part in this important program," Dr. Saks continued.

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 t
'/>"/>

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

Page: 1 2 3

Related medicine technology :

1. Aegerion Pharmaceuticals, Inc. adds Peter Garrambone to Board of Directors, Secures Additional Capital for Clinical Trials
2. Rib-X Pharmaceuticals, Inc. Announces Recent and Upcoming Presentations at Scientific Conferences
3. Meditrina Pharmaceuticals, Inc. Opens Investigational New Drug (IND) Application for Phase IIb Clinical Trial With MPI-676 in Endometriosis
4. Keryx Biopharmaceuticals, Inc. Announces Phase 2 Results on KRX-0401 (Perifosine) in Patients with Relapsed/Refractory Waldenstroms Macroglobulinemia at the 44th Annual Meeting of the American Society of Clinical Oncology
5. Auxilium Pharmaceuticals, Inc. Announces XIAFLEX(TM) Meets Primary Endpoint With Statistical Significance (p<0.001) in CORD I Pivotal Phase III Study for Dupuytrens Contracture
6. Keryx Biopharmaceuticals, Inc. Announces Poster Presentation Highlighting Observed Clinical Activity of KRX-0401 (Perifosine) at the American Society of Clinical Oncology Meeting in Chicago, Illinois
7. Jazz Pharmaceuticals, Inc. Completes Enrollment in First of Two Phase III Clinical Trials of Sodium Oxybate to Treat Fibromyalgia
8. Arena Pharmaceuticals, Inc. Announces Initiation of Phase 1 Clinical Trial of Drug Candidate Under Partnership with Taisho Pharmaceutical Co., Ltd.
9. 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
10. Lotus Pharmaceuticals, Inc. Achieves Significant Milestones in the Development of Isosorbide Mononitrate Sustained Release Tablets
11. Jazz Pharmaceuticals, Inc. Announces Receipt of FDA Orphan Drug Designation for Recurrent Acute Repetitive Seizures Product Candidate
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/22/2015)... UPI ), a medical device company that develops, ... dysfunctions, today reported financial results for the fiscal 2015 ... for the Company,s Urgent ®  PC Neuromodulation System grew ... as compared to $3.9 million in the third quarter ...
(Date:1/22/2015)... Jan. 22, 2015  Amgen (NASDAQ: AMGN ) today announced ... financial results on Tuesday, Jan. 27, 2015, after the close of ... conference call with the investment community at 2 p.m. PT. Participating ... , chairman and chief executive officer, and other members of Amgen,s ...
(Date:1/22/2015)... Increasing sophistication among enterprise buyers of language services ... 2015, says Moravia CMO, Renato Beninatto ... market research firm Common Sense Advisory, 15 percent of ... and localization needs. "From a language industry perspective, this ...
Breaking Medicine Technology:Uroplasty Reports Record Revenue in Fiscal Third Quarter 2Uroplasty Reports Record Revenue in Fiscal Third Quarter 3Uroplasty Reports Record Revenue in Fiscal Third Quarter 4Uroplasty Reports Record Revenue in Fiscal Third Quarter 5Uroplasty Reports Record Revenue in Fiscal Third Quarter 6Uroplasty Reports Record Revenue in Fiscal Third Quarter 7Uroplasty Reports Record Revenue in Fiscal Third Quarter 8Uroplasty Reports Record Revenue in Fiscal Third Quarter 9Uroplasty Reports Record Revenue in Fiscal Third Quarter 10Uroplasty Reports Record Revenue in Fiscal Third Quarter 11Uroplasty Reports Record Revenue in Fiscal Third Quarter 12Uroplasty Reports Record Revenue in Fiscal Third Quarter 13Uroplasty Reports Record Revenue in Fiscal Third Quarter 14Uroplasty Reports Record Revenue in Fiscal Third Quarter 15Uroplasty Reports Record Revenue in Fiscal Third Quarter 16Uroplasty Reports Record Revenue in Fiscal Third Quarter 17Uroplasty Reports Record Revenue in Fiscal Third Quarter 18Amgen Announces Webcast of 2014 Fourth Quarter and Full Year Financial Results 2Moravia Sees Single-Sourcing as Key Localization Trend in 2015 2
... 25, 2011 Prolong Pharmaceuticals, which in October secured ... group, today announced the signing of a long term ... Jersey and the formal addition of Dr. Hemant Misra ... Manufacturing and Facilities Operations. The manufacturing ...
... announces that a new market research report is available ... for Assisted Living Technologies ... European markets for assisted living technologies, presenting the market ... on competitive and technology trends present in various sector ...
Cached Medicine Technology:Prolong Pharmaceuticals Leases 24,000-Square-Foot Manufacturing Facility, Adds Facilities Veteran to Executive Team 2
(Date:1/22/2015)... Bradley, Illinois (PRWEB) January 22, 2015 Deer ... -- will host a Valentine’s Day Happy Hour from 3 p.m. ... located at 12500 Regency Parkway in Huntley, Illinois, serves adults with ... Happy Hour event will include Valentine's Day treats, games and sweetheart-themed ...
(Date:1/22/2015)... 22, 2015 Liberty University has received accreditation ... program from the Council for Accreditation of Counseling & ... Liberty’s Center for Counseling & Family Studies , is ... the university’s new School of Behavioral Sciences. Prior to the ...
(Date:1/22/2015)... The City of West Hollywood hosted a news conference on ... anniversary of the Supreme Court decision Roe v. Wade, which legalized ... the Roe vs. Wade decision and the fight to protect a ... City of West Hollywood Councilmember Abbe Land. “We need to continue ...
(Date:1/22/2015)... 22, 2015 Gabe’s Chemo Duck Program is pleased ... first app ever created for kids with cancer. The Chemo Duck ... devices, is filled with enjoyable games to help children of all ... free app helps to keep kids entertained, educated and at ease ...
(Date:1/22/2015)... is a seasoned and trusted leader who consistently delivers trendy ... have it lead the wedding dress industry into the future. ... for the global market. , “The CEO of VogueQueen is ... on continuing the goal of operational excellence and giving back ...
Breaking Medicine News(10 mins):Health News:Deer Path of Huntley Affordable Assisted Living to Host Valentine's Day Happy Hour 2Health News:Liberty University's Resident Master’s Counseling Program Receives CACREP Accreditation 2Health News:Chemo Duck Launches First App Ever Created for Kids with Cancer 2Health News:Chemo Duck Launches First App Ever Created for Kids with Cancer 3Health News:VogueQueen Unveils New Designs of Prom Dresses for 2015 2
... procedure, study finds , TUESDAY, April 13 (HealthDay News) ... lowers the risk that obese women will develop major ... , Obese women, particularly those who are extremely so, ... preeclampsia during pregnancy. These types of disorders, also called ...
... Federal reports also say health care providers can do ... (HealthDay News) -- U.S. hospitals are making little progress ... according to reports released April 13 by the federal ... National Healthcare Quality Report and the National Healthcare Disparities ...
... and young age increased risk, Singapore researchers say , TUESDAY, ... those serving in the military and young adults showed higher ... last year. , Almost 30 percent of military personnel, who ... 13.5 percent in the general population, 6.5 percent of hospital ...
... new study seemed unlikely to have body image issues ... screening presented no red flags. That assessment changed ... observe what happened in the brain when people viewed ... to be overweight and female, it surprisingly activated in ...
... Tim Obrenski found himself getting so exhausted that he couldn,t even ... a major blockage in his heart,s left main artery, and he ... Obrenski,s search for alternatives to surgery brought him to UCLA interventional ... is the gold standard in most of these cases, angioplasty with ...
... release is available in French . ... has been selected by Montral,s International Laboratory for Brain, ... in-ear, digital signal processing devices (DSP) to investigate experience-dependent ... us to change a person,s sound perception, in real ...
Cached Medicine News:Health News:Weight-Loss Surgery May Ease Childbirth Risks 2Health News:U.S. Hospitals Get Low Marks on Curbing Infections 2Health News:Study Finds Military Prone to Infection With H1N1 Flu 2Health News:Study Finds Military Prone to Infection With H1N1 Flu 3Health News:Fear of getting fat seen in healthy women's brain scans 2Health News:UCLA study compares bypass surgery to angioplasty 2Health News:New research tools for BRAMS via Sonomax Technologies 2
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
Medicine Products: