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Pregabalin (Lyrica) Is First Drug Approved for Fibromyalgia

Pregabalin (Lyrica) Is First Drug Approved for Fibromyalgia

ROCKVILLE, Md., June 22 -- The FDA has approved pregabalin (Lyrica) for treatment of fibromyalgia.

The agency said that pregabalin, which was already approved for partial seizures and symptomatic relief of shingles and diabetic neuropathy, is the first drug to win an indication for fibromyalgia, a disorder characterized by pain, fatigue, and sleep problems.

But Steven Galson, M.D., M.P.H., director of the FDA's Center for Drug Evaluation and Research, cautioned that the drug was not a panacea because response to the drug was not universal.

In a pair of studies reported last month at the American Psychiatric Association meeting, the response rate varied from about 30% to 60%.


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