The U.S. Food and Drug Administration today approved Cymbalta (duloxetine hydrochloride) to
treat chronic musculoskeletal pain, including discomfort from osteoarthritis and chronic lower back
pain. Cymbalta was first used to treat major depressive disorder in 2004.
initial approval, about 30 million patients in the United States have used Cymbalta. It was
approved for the treatment of diabetic peripheral neuropathy in 2004; generalized anxiety disorder
and maintenance treatment of major depression in 2007; and fibromyalgia in 2008.
More than 29,000 patients have used Cymbalta in clinical trials, and more than 600 patients were
studied in the clinical trials involving osteoarthritis and chronic low back pain. The safety
evaluation for Cymbalta included review of data from the clinical trials as well as post-marketing
data from the previously approved patient populations.
The FDA assessed the efficacy
of Cymbalta in chronic low back pain and osteoarthritis in four double-blind, placebo-controlled,
randomized clinical trials. At the end of the study period, patients taking Cymbalta had a
significantly greater pain reduction compared with placebo.
For more information,
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