PALO ALTO, Calif., Feb. 18 /PRNewswire-FirstCall/ -- Jazz Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for JZP-6 (sodium oxybate) for the treatment of fibromyalgia. Based on a standard 10-month review, the target date for the FDA to complete its review of the NDA under the Prescription Drug User Fee Act (PDUFA) is October 11, 2010.
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.
About Fibromyalgia
Fibromyalgia is a chronic condition characterized by widespread pain. 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.
Jazz Pharmaceuticals, Inc.
