Published on December 15, 2009 at 7:46 AM
Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for JZP-6 (sodium oxybate oral solution) for the treatment of fibromyalgia.
The submission is based on a comprehensive clinical development program for JZP-6, including results from two Phase III clinical trials. In both trials, sodium oxybate significantly decreased pain and fatigue as well as improved daily function, patient global impression of change, and sleep quality. Sodium oxybate has not been evaluated by regulators for the treatment of fibromyalgia and is not approved for this use.
Fibromyalgia is a complex musculoskeletal disorder clinically characterized by widespread pain usually accompanied by fatigue, insomnia, and dyscognition. According to the American College of Rheumatology (ACR), an estimated 6 million Americans suffer from fibromyalgia.
SOURCE Jazz Pharmaceuticals, Inc.
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Posted in: Medical Condition News | Pharmaceutical News
Tags: Brain, Depression, Fibromyalgia, Genetics, Insomnia, Narcolepsy, Nausea, Nervous System, Neurology, New Drug Application, Physiology, Psychiatry, Rheumatology, Sleep, Stress, Trauma