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Lilly's Cymbalta approved for new use

Eli Lilly's antidepressant Cymbalta has been cleared by the US Food and Drug Administration for the treatment of chronic musculoskeletal pain

Eli Lilly's blockbuster antidepressant Cymbalta (duloxetine) has been cleared by the US Food and Drug Administration (FDA) for the new indication of treatment of chronic musculoskeletal pain, including discomfort from osteoarthritis and chronic lower back pain.

This is the fifth indication to be approved for Cymbalta by the FDA. The drug, which was originally cleared for marketing in the US in 2004 for the treatment of diabetic peripheral neuropathy, received subsequent approvals for generalised anxiety disorder and maintenance treatment of major depression in 2007 and fibromyalgia in 2008.

The marketing application for the latest indication was supported by relatively small clinical studies enrolling about 600 patients with chronic low back pain or chronic pain due to osteoarthritis who received Cymbalta or placebo once a day.  The safety evaluation for Cymbalta was based in large part on post-marketing data from the previously approved patient populations.

The approval offers a new non-narcotic alternative for patients who suffer from chronic musculoskeletal pain, according to Lilly. The company said that new options can be particularly important for patients with this type of pain because response to treatment is highly individualised.

It is unknown precisely how Cymbalta reduces chronic musculoskeletal pain, but the drug likely enhances the body's natural pain-suppressing system by increasing activity of serotonin and norepinephrine in the brain and spinal cord.

5th November 2010

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