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FDA Approves Cymbalta(R) for the Management of Fibromyalgia
Date:6/16/2008

medications to help reduce the chronic, widespread pain of this life-altering disorder," said Lynne Matallana, president of the National Fibromyalgia Association and a fibromyalgia patient.

Fibromyalgia is estimated to affect 2 percent of the U.S. population - approximately 5 million people - the majority of those diagnosed being women.(iv),(v) The disorder is characterized by chronic widespread pain and tenderness. Some patients may have additional symptoms.(i) Although there is no known cure for fibromyalgia, some physicians recommend a comprehensive care plan that can include education, medication, and lifestyle changes to help manage the symptoms of the disorder.(i)

"In fibromyalgia, there is no one-size-fits-all approach to managing the disorder," said Dan Clauw, M.D., professor of medicine in the University of Michigan's Division of Rheumatology and director of the Chronic Pain and Fatigue Research Center at the University of Michigan.

The approval marks the fourth disorder that the FDA has approved for Cymbalta. In addition to fibromyalgia, Cymbalta is approved for the management of diabetic peripheral neuropathic pain (DPNP) and the treatment of major depressive disorder and generalized anxiety disorder, all in adults age 18 years and older.

Additional important changes have been made to the Cymbalta prescribing information, including updates to the Warnings and Precautions section. Full prescribing information can be found at http://www.cymbalta.com.

Data Highlights

Lilly established the efficacy of Cymbalta in two pivotal three-month clinical trials involving 874 patients with fibromyalgia. In both studies, Cymbalta reduced pain at study endpoint compared with placebo as measured by the Brief Pain Inventory (BPI) 24-hour average pain scale.(vi),(vii) The BPI is a scale that measures the severity of pain.

Significant improvement in pain for Cymbalta vs. pla
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SOURCE Eli Lilly and Company
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