New Drug Application for sodium oxybate as fibromyalgia treatment accepted by FDA

Jazz Pharmaceuticals, Inc. announced Feb 19 that the U.S. Food and Drug Administration (FDA) had accepted for filing the New Drug Application for the prescription drug JZP-6 (sodium oxybate, brand name Xyrem®) for the treatment of fibromyalgia symptoms. Xyrem is a central nervous system depressant. It is now FDA approved and available only under a special program for patients with narcolepsy – to support night time drowsiness and thus reduce excessive daytime sleepiness and sudden loss of muscle strength. (It is also a street drug of abuse – known as “GHB.”)

Fibromyalgia studies have focused on the drug’s ability to improve sleep quality, fatigue, and pain.

According to the company’s press release:

“Based on a standard 10-month review, the target date for the FDA to complete its review of the New Drug Application under the Prescription Drug User Fee Act (PDUFA) is October 11, 2010.

“The submission is based on a comprehensive clinical development program 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 was generally well tolerated, with the majority of adverse events reported being mild to moderate in nature and similar to those seen in previous trials with narcolepsy. Sodium oxybate has not been evaluated by regulators for the treatment of fibromyalgia and is not approved for this use.”
Note: For background, see for example the full text article “Sodium oxybate relieves pain and improves function in fibromyalgia syndrome: A randomized, double-blind, placebo-controlled, multicenter clinical trial,”  Arthritis & Rheumatism, Jan 2009, by Russel J, Perkins AT, Michalet, JE.

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