FDA Approves New Use for Cymbalta: Chronic Musculoskeletal Pain
On Friday, the U.S. Food and Drug Administration (FDA) approved Cymbalta (Duloxetine hydrochloride) for use as a treatment for chronic musculoskeletal pain, including discomfort from osteoarthritis and chronic lower back pain.
Cymbalta, originally approved in 2004 for the treatment of diabetic peripheral neuropathy, was also approved for generalized anxiety disorder and maintenance treatment of major depression in 2007, and fibromyalgia in 2008. In 2008 Eli Lily and Company, the company that makes Cymbalta, filed an application with the FDA to allow the drug to be prescribed for the management of chronic back pain. The drug maximizes serotonin and norepinephrine, which are two messenger chemicals in the brain.
Eli Lily had funded several studies testing the use of Cymbalta as a treatment for chronic back pain. One of the studies proved effective on relieving chronic back pain in patients who were prescribed 60-120 milligrams of Cymbalta. There were 236 adults suffering with chronic back pain who participated in the study. They did not suffer from depression. Almost one-third of the group who took Cymbalta reported their lower back pain was cut in half after the trial. Some side effects did occur during the study, but they were all compatible with side effects from Cymbalta.
“Up to three quarters of the population experience chronic pain at some time in their lives," said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research. “This approval means that many of those people now have another treatment option.”
According to the FDA press release, since its initial approval, about 30 million patients in the United States have used Cymbalta. 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.
Nov 10, 2010