JZP-6Treatment for Fibromyalgia
Jazz Pharmaceuticals' JZP-6 to be Reviewed at a Joint Meeting of the FDA's Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee on August 20, 2010
PALO ALTO, Calif., June 24 /PRNewswire-FirstCall/ -- Jazz Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration's (FDA) Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee will review JZP-6 (sodium oxybate) for the treatment of fibromyalgia at a joint meeting on August 20, 2010.
In February 2010, the FDA accepted for filing and review the New Drug Application (NDA) of JZP-6 (sodium oxybate) for the treatment of fibromyalgia. 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.
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® (sodium oxybate) oral solution, approved by the FDA and marketed by Jazz Pharmaceuticals in the U.S. for the treatment of excessive daytime sleepiness and cataplexy (the sudden loss of muscle tone) in adult patients with narcolepsy. The 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.
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.
About Jazz Pharmaceuticals, Inc.
Jazz Pharmaceuticals (NASDAQ:JAZZ) is a specialty pharmaceutical company that identifies, develops and commercializes innovative treatments for important, underserved markets in neurology and psychiatry. For further information see www.jazzpharmaceuticals.com.
Source: Jazz Pharmaceuticals, Inc.
CONTACT: Shawn Mindus, Senior Director of Financial Planning, Analysis and Strategy of Jazz Pharmaceuticals, Inc., +1-650-496-3777, email@example.com
Web Site: http://www.jazzpharmaceuticals.com/
Posted: June 2010
- Jazz Pharmaceuticals Receives FDA Complete Response Letter Regarding JZP-6 for Treatment of Fibromyalgia - October 11, 2010
- Jazz Pharmaceuticals Provides Update on FDA Advisory Committee Meeting For JZP-6 (Sodium Oxybate) in Fibromyalgia - August 23, 2010
- Jazz Pharmaceuticals Announces FDA Acceptance of its New Drug Application for JZP-6 (sodium oxybate) for the Treatment of Fibromyalgia - February 19, 2010
- Jazz Pharmaceuticals Submits New Drug Application for JZP-6 (sodium oxybate) for the Treatment of Fibromyalgia - December 15, 2009