Navigation Links
Jazz Pharmaceuticals, Inc. Completes Enrollment in Second of Two Phase III Clinical Trials of Sodium Oxybate to Treat Fibromyalgia
Date:1/13/2009

PALO ALTO, Calif., Jan. 13 /PRNewswire-FirstCall/ -- Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) today announced completion of enrollment in the second of two Phase III pivotal clinical trials of JZP-6 (sodium oxybate) for the treatment of fibromyalgia.

"Completion of enrollment in this second trial is a meaningful milestone in the JZP-6 program in fibromyalgia. We expect to report top-line results from this trial in mid-2009," 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 was completed and positive top-line results were announced in November 2008. The second Phase III study has enrolled 575 patients at centers in the U.S. and Europe.

Jazz Pharmaceuticals anticipates submitting a New Drug Application for sodium oxybate to the U.S. Food and Drug Administration by the end of 2009. UCB has the exclusive marketing and distribution rights to sodium oxybate for fibromyalgia in Europe and many other countries outside North America.

About Sodium Oxybate

Sodium oxybate is the sodium salt form of gamma-hydroxybutyrate, an endogenous neurotransmitter and metabolite of GABA. While the precise mechanism of action is unknown, the effects may be mediated in part through interaction with GABA(B) and GHB receptors. Sodium oxybate is the active ingredient in XYREM(R), approved by the FDA for the treatment of excessive daytime sleepiness (EDS) and cataplexy (the sudden loss of muscle tone) in adult patients with narcolepsy. The American Academy of Sleep Medicine recommends sodium oxybate as a standard of care for the U.S. Food and Drug Administration-approved indications. It is also approved by the European Medical Evaluation Agency (EMEA) for the treatment o
'/>"/>

SOURCE Jazz Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3

Related medicine technology :

1. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
2. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
3. Quark Pharmaceuticals, Inc. Presented Positive Preclinical Results of Systemic RNAi Compound for Acute Renal Failure (ARF)
4. Acura Pharmaceuticals, Inc. Secures Financing to Fund Pivotal Phase III Clinical Trial for Lead Aversion(R) Technology Product Candidate
5. Sucampo Pharmaceuticals, Inc. Begins Pivotal Phase III Studies of Oral Lubiprostone to Treat Opioid-Induced Bowel Dysfunction (OBD)
6. Symbollon Pharmaceuticals, Inc. Evaluates the Clinical Effects of IoGen(TM) on Fibrocystic Breast Disease
7. Aegerion Pharmaceuticals, Inc. Presents Final Results of Phase II Clinical Trials for AEGR-733 at Drugs Affecting Lipid Metabolism (DALM) 2007 Conference
8. Keryx Biopharmaceuticals, Inc. Announces Positive Preliminary Phase 2 Data on KRX-0401 in Patients with Chemo-Insensitive Rare Sarcoma
9. Quark Pharmaceuticals, Inc. Announces First Systemic siRNA Dosing in Humans
10. 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
11. Solvay Pharmaceuticals, Inc. Responds to Advisory Committee Recommendation for Further Study of Tedisamil to Treat Atrial Fibrillation
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/22/2013)... Calif. , May 22, 2013 Cellular Biomedicine ... of the enrollment of the total projected enrollment required for ... efficacy of TC-DC (Tumor Stem Cell Specific Dendritic Cell) therapy ... cancer. To date the trial has had no Severe Adverse ... for TC-DC therapy for HCC, registered with NIH under number ...
(Date:5/22/2013)... Assured Pharmacy, Inc. (APHY), a leading pharmacy ... of chronic pain, announced it has engaged Hayden IR, ... to raise its visibility and strengthen its relationships with ... we have proven our business model and derived a ... two additional new pharmacies in Denver ...
(Date:5/21/2013)... -- Concord Medical Services Holdings Limited ("Concord Medical" or ... specialty hospital management solution provider and operator of the ... China and the parent of Chang,an Hospital, today reported ... ended March 31, 2013 [1] . First ... consists of net revenues generated from the network business ...
Breaking Medicine Technology:Cellular Biomedicine Group Announces Enrollment Milestone for Phase I Clinical Trial for Liver Cancer 2Cellular Biomedicine Group Announces Enrollment Milestone for Phase I Clinical Trial for Liver Cancer 3Assured Pharmacy Hires Hayden IR 2Assured Pharmacy Hires Hayden IR 3Concord Medical Reports First Quarter 2013 Financial Results 2Concord Medical Reports First Quarter 2013 Financial Results 3Concord Medical Reports First Quarter 2013 Financial Results 4Concord Medical Reports First Quarter 2013 Financial Results 5Concord Medical Reports First Quarter 2013 Financial Results 6Concord Medical Reports First Quarter 2013 Financial Results 7Concord Medical Reports First Quarter 2013 Financial Results 8Concord Medical Reports First Quarter 2013 Financial Results 9Concord Medical Reports First Quarter 2013 Financial Results 10Concord Medical Reports First Quarter 2013 Financial Results 11Concord Medical Reports First Quarter 2013 Financial Results 12Concord Medical Reports First Quarter 2013 Financial Results 13
...   Remedi SeniorCare , one of the nation,s largest ... assisted living and retirement communities, announced that effective Dec. ... care pharmacy to have its electronic order entry software ... electronic prescribing.  "This is an incredibly ...
... Inc. (NYSE: HSP ), the world,s leading ... of the first patient in a Phase III U.S. clinical ... which follows a successful Phase I trial that concluded last ... the reference product, Amgen,s Epogen ® in patients with ...
Cached Medicine Technology:Remedi SeniorCare® Wins Ohio State Board of Pharmacy's First and Only Approval for Electronic Prescribing in State of Ohio 2Hospira Announces Start of U.S. Phase III Biosimilar EPO Clinical Program 2Hospira Announces Start of U.S. Phase III Biosimilar EPO Clinical Program 3
(Date:5/21/2013)... Swimsuit season is almost here. The "Get Ready for ... with a 35% discount. , Cellulite forms mainly in women ... dreaded cellulite even if they are in shape. Cellulite ... been stored as toxic lymph and smashed together, giving the ... program that works to dissolve the toxins and fatty deposits ...
(Date:5/21/2013)... 22, 2013 Feed additives have now ... industry value chain. Most of the feed additives are ... pellets, liquids, and powders. There are variety of feed ... concentrations depending upon the type of animal and feed. ... that provide essential nutrition to the animal in order ...
(Date:5/21/2013)... Washington (GW) University School of Public Health ... of the Avance Center for the Advancement ... the Maryland Multicultural Youth Centers, the Rivera ... partnership aims to address public health problems ... mutual capacity building and prevention efforts. , ...
(Date:5/21/2013)... Medical Ministry International announced today that ... by GreatNonprofits , the leading provider of user reviews ... a Top-Rated 2013 Nonprofit,” says Samuel Smith, MMI CEO. ... 3000 Volunteers and Staff serving in 22 countries around the ... those that have seen our work first hand and wanted ...
(Date:5/21/2013)... DISCcert has served the training industry ... 17 DISC applications at the July 25 & 26th ... The July 25 & 26th DISC certification in San ... applying DISC. The time-tested, proven support materials will include ... DISC training materials ; worksheets, handouts, learning activities, ...
Breaking Medicine News(10 mins):Health News:Diminish Cellulite for Swimsuit Season; Sublime Beauty Introduces Cellulite Whisperer® Products in the "Get Ready for Summer Sale" 2Health News:Protease Leads Feed Enzyme Market as Compared to Phytase & NSP Says New Research Report at ReportsnReports.com 2Health News:Protease Leads Feed Enzyme Market as Compared to Phytase & NSP Says New Research Report at ReportsnReports.com 3Health News:Protease Leads Feed Enzyme Market as Compared to Phytase & NSP Says New Research Report at ReportsnReports.com 4Health News:GW launches center to address health disparities in the Latino immigrant community 2Health News:GW launches center to address health disparities in the Latino immigrant community 3Health News:Medical Ministry International Recognized as a 2013 Top-rated Nonprofit By GreatNonprofits.org 2Health News:DISCcert Offers 17 Applications in Coming DISC Certification 2Health News:DISCcert Offers 17 Applications in Coming DISC Certification 3Health News:DISCcert Offers 17 Applications in Coming DISC Certification 4
... 4 1/2-Year Fight Shows Need for Labor Law Reform , ... workers at Enloe Medical Center have reached a tentative agreement with ... care, full health coverage for workers, and an average wage increase ... If approved, the contract would cap more than a ...
... YORK, Dec. 3 Ten students pursuing health care careers ... $2,000 scholarships from the National Hispanic Health Foundation (NHHF) at ... 7 p.m.December 4 at the New York Marriott Marquis Hotel. ... program was supported by United Health Foundation, who donated $15,000 ...
... A patient who was surgically implanted,with Medtronic,s Infuse(R) ... suffocated due to severe throat and neck swelling, according ... Perry, LLC who filed the lawsuit,in California along with ... The Complaint alleges, among other things, that ...
... Council,(MQC) announces that the Detroit Athletic Club is a 2008 ... The Michigan Quality Leadership Award is the highest honor for,organizational ... a,rigorous review by a team of examiners who perform a ... to an independent panel of,judges. , ...
... Dec. 3 Vertellus Specialties Inc., a leading specialty chemicals ... 1, 2009 for 2-vinylpyridine monomer sales to all non-contract customers. ... in production capacity and to provide better supply chain logistics ... About Vertellus Specialties Inc. , ...
... asthma education program conducted in the Oakland, California school district ... days that children who suffered from asthma were able to ... in the Journal of School Health . , Nearly ... according to the Centers for Disease Control and Prevention. The ...
Cached Medicine News:Health News:Healthcare Workers Reach Tentative Agreement With Enloe Medical Center 2Health News:NHHF Scholarship Program Targets Growing Demand for Diversity Among Health Care Professionals 2Health News:Medtronic, Inc. and Medtronic Sofamor Danek, USA, Inc. Sued for Product Liability and Promoting the Off-Label Use of Infuse(R) Bone Graft Product, According to Page Perry, LLC 2Health News:MICHIGAN QUALITY COUNCIL (MQC) NAMES The Detroit Athletic Club 2008 STATE QUALITY AWARD RECIPIENT 2Health News:Study shows school-based program enables children and adolescents to better manage chronic disease 2
... 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 ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
Medicine Products: