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FDA Approves Cymbalta® for the Management of Chronic Musculoskeletal Pain
Date:11/4/2010

INDIANAPOLIS, Nov. 4, 2010 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has approved Cymbalta® (duloxetine HCl) for the management of chronic musculoskeletal pain. This has been established in studies in patients with chronic low back pain and chronic pain due to osteoarthritis. This is the fifth indication the FDA has approved for Cymbalta.

Cymbalta, which has been shown to significantly reduce chronic low back pain and chronic pain due to osteoarthritis, is a non-narcotic pain reliever that is meant to be taken once a day, every day by people with these pain conditions.

"People with chronic musculoskeletal pain often struggle to find a medication that works for them. The approval of Cymbalta for chronic musculoskeletal pain by the FDA gives doctors another option to help an underserved and suffering group of patients," said Michael Clark, M.D., MPH, director, Chronic Pain Treatment Program, Department of Psychiatry and Behavioral Sciences, The Johns Hopkins Medical Institutions.

Although the exact way that Cymbalta works to reduce chronic musculoskeletal pain is unknown, it is believed that Cymbalta helps lessen pain by enhancing the body's natural pain suppressing system by increasing the activity of serotonin and norepinephrine in the brain and spinal cord.

In chronic musculoskeletal pain clinical studies, the most commonly observed adverse events (those occurring in at least 5 percent of study participants taking Cymbalta and at least twice the rate of placebo) in Cymbalta-treated patients with chronic low back pain were nausea, dry mouth, insomnia, sleepiness, constipation, dizziness and fatigue. The most commonly observed adverse events in Cymbalta-treated patients with chronic pain due to osteoarthritis were nausea, fatigue and constipation.

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SOURCE Eli Lilly and Company
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