Thursday, Jazz Pharmaceuticals, Inc. (JAZZ) said that the U.S. Food and Drug Administration's Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee will review JZP-6 or sodium oxybate for the treatment of fibromyalgia at a joint meeting on August 20.
In February, the FDA accepted for filing and review the New Drug Application or NDA of JZP-6 to treat fibromyalgia. The target date for the FDA to complete its review of the NDA under the Prescription Drug User Fee Act or PDUFA is October 11.
Fibromyalgia is a chronic condition characterized by widespread pain. It 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 the disease are unknown.
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