Navigation Links
Data from Jazz Pharmaceuticals' First Phase III Study of Sodium Oxybate in Patients With Fibromyalgia to be Presented at Upcoming Conferences

PALO ALTO, Calif., Oct. 14 /PRNewswire-FirstCall/ -- Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) announced today that data from the company's first Phase III clinical trial of sodium oxybate (JZP-6) for the treatment of fibromyalgia will be presented next week during the American College of Rheumatology 2009 Annual Meeting (ACR) in Philadelphia, Pennsylvania and also in November during the US Psychiatric and Mental Health Congress (US Psych Congress) in Las Vegas, Nevada.

  • At ACR on October 20, 2009, I. Jon Russell, MD, PhD, Associate Professor of Medicine in the Division of Clinical Immunology and Rheumatology and Director, University Clinical Research Center at The University of Texas Health Science Center at San Antonio, will present a poster entitled, "Effect of Sodium Oxybate on Pain, Functionality, PGIc, & Composite Scores in Fibromyalgia - Results from a Phase 3 Controlled Trial". The poster will be presented in the 9:00 am - 11:00 am poster session.
  • Also at ACR on October 20, 2009, Philip J. Mease, MD, Clinical Professor at the University of Washington School of Medicine in Seattle and Chief of Rheumatology Clinical Research at the Swedish Hospital Medical Center, will present a poster entitled, "Sodium Oxybate Improves Fatigue, Sleep Disturbance, and PGIc in Fibromyalgia - Results from a Phase 3, 14-Week Controlled Trial". The poster will be presented in the 9:00 am - 11:00 am poster session.
  • At US Psych Congress on November 2, 2009, Stephen S. Flitman, MD, Medical Director at 21st Century Neurology, a division of Xenoscience, will present a poster entitled, "Efficacy and Safety of Sodium Oxybate in Fibromyalgia: A 14-week, Randomized, Double-blind, Controlled Trial". The poster will be presented in the 3:45 pm - 6:45 pm poster session.

Jazz Pharmaceuticals has completed two Phase III pivotal clinical trials of JZP-6, with positive results in both studies. Jazz Pharmaceuticals is working to submit a New Drug Application for sodium oxybate for the treatment of fibromyalgia to the U.S. Food and Drug Administration by the end of 2009.

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®, approved by the FDA for the treatment of excessive daytime sleepiness 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 for the treatment of narcolepsy with cataplexy in adult patients. Most commonly reported adverse drug reactions in narcolepsy patients are dizziness, nausea and headaches. Sodium oxybate has the potential to induce respiratory depression and neuropsychiatric events. Sodium oxybate has not been evaluated by regulators for the treatment of fibromyalgia and is not approved for this use.

About Fibromyalgia

Fibromyalgia, a chronic condition characterized by widespread pain, affects 0.5% - 5% of adults worldwide. Fibromyalgia is believed to be a central nervous system condition, resulting from neurological changes in how the brain perceives and responds to pain. In addition to pain, the main symptoms are fatigue, disturbed sleep and morning stiffness. The exact causes of fibromyalgia are unknown. It may be triggered by physical trauma, emotional stress, chronic pain or infection. Genetics, neurochemicals that affect pain modulation, neurohormones and sleep physiology abnormalities are thought to play a role. Research also has suggested a relationship between sleep and pain. Fibromyalgia patients experience a high prevalence of sleep problems, including a reduction in non-restorative or deep sleep.

About Jazz Pharmaceuticals, Inc.

Jazz Pharmaceuticals is a specialty pharmaceutical company that identifies, develops and commercializes innovative treatments for important, underserved markets in neurology and psychiatry. For further information please see

SOURCE Jazz Pharmaceuticals, Inc.

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

Related medicine technology :

1. Timm Medical Technologies and Ferring Pharmaceuticals Enter Exclusive Co-Promotion Agreement for Prosed(R) DS
2. China Yongxin Pharmaceuticals Inc. Announces Second Quarter 2009 Financial Results
3. VIA Pharmaceuticals Receives Favorable Hearing Decision From NASDAQ
4. Vanda Pharmaceuticals Enters into an Exclusive License Agreement for the Commercialization and Development of Fanapt(TM) in the U.S. and Canada for the Treatment of Schizophrenia
5. Vion Pharmaceuticals Engages Merriman Curhan Ford to Evaluate Strategic Alternatives
6. Arena Pharmaceuticals Lorcaserin to be Featured in Multiple Presentations at Obesity 2009
7. Onyx Pharmaceuticals to Acquire Proteolix, Inc.
8. Onyx Pharmaceuticals Announces Investor Teleconference and Webcast
9. ADVENTRX Pharmaceuticals Announces Closing of Financing
10. Savient Pharmaceuticals Prices Underwritten Offering of Common Stock
11. Endo Pharmaceuticals to Announce Third Quarter 2009 Financial Results on October 29, 2009
Post Your Comments:
(Date:11/30/2015)... VIEW, Calif. , Nov. 30, 2015 ... been the norm in U.S. medical imaging ... The increasingly popular accountable care payer-provider contracts ... models and, in their wake, alter provider-vendor ... quality-based payments will push forward new purchasing ...
(Date:11/30/2015)... and SAN DIEGO , ... Pharmaceuticals, Inc. (NASDAQ: ARNA ) today announced that ... for filing the New Drug Application (NDA) for an ... release formulation will offer patients a chronic weight management ... ® ) is currently approved as an adjunct to ...
(Date:11/30/2015)... and ST. LOUIS , Nov. 30, ... ESRX ) today announced an early renewal of ... began in 1999, will now extend through at least ... After evaluating pharmacy benefit manager capabilities during a ... Scripts continues to offer the best health plan integration ...
Breaking Medicine Technology:
(Date:11/30/2015)... ... November 30, 2015 , ... RoamRight, a leading provider of travel insurance ... Television’s Travel With Kids to promote family vacations around the world. The television ... international destinations and educate families about the people and places of the world, all ...
(Date:11/30/2015)... (PRWEB) , ... November 30, 2015 , ... At Grand ... comfortable and convenient setting. , When you have dental problems, you need to turn ... and can effectively diagnose and treat your needs, a friendly dentist who counsels you ...
(Date:11/30/2015)... ... November 30, 2015 , ... Newly reviewed ... of Glen Ridge, NJ. He has both advanced training and considerable experience ... is also an expert in cosmetic dentistry. He is an active Spear ...
(Date:11/30/2015)... ... November 30, 2015 , ... ”Dying Words: The AIDS Reporting of Jeff Schmalz ... 2015, to coincide with World AIDS Day. The multi-media project will be in audio ... epidemic as he was dying of the disease. , A collaborative effort led by ...
(Date:11/30/2015)... PA (PRWEB) , ... November 30, 2015 , ... ... Specialty Ingredients (ASI) as their exclusive channel partner for the Nutraceutical Specialties products ... markets in the US, effective immediately. , “We are pleased to announce ...
Breaking Medicine News(10 mins):