Oct 15 2009
Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) announced that data from the company's first Phase III clinical trial of sodium oxybate (JZP-6) for the treatment of fibromyalgia will be presented 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.
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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.
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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.
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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.