FDA Approves Cymbalta to Treat Chronic Musculoskeletal Pain
FDA Clears Cymbalta to Treat Chronic Musculoskeletal Pain
Indications include osteoarthritis, chronic lower back pain
ROCKVILLE, Md., Nov. 4, 2010--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.
"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."
Since its 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.
The most common side effects reported with Cymbalta include nausea, dry mouth, insomnia, drowsiness, constipation, fatigue, and dizziness. Other serious side effects include liver damage, allergic reactions such as hives, rashes and/or swelling of the face, pneumonia, depressed mood, suicide, suicidal thoughts and behavior.
While these serious side effects have been associated with the use of Cymbalta, they have occurred in less than 1% of treated patients. There are a finite number of drugs available for the treatment of chronic musculoskeletal pain, all of which are associated with rare, serious side effects. There are patients in whom none of the available treatments are effective.
The recommended dose for Cymbalta is a 60 milligram capsule taken once daily without regard to meals. The capsule should be swallowed whole, and not chewed, crushed or opened; the contents should never be sprinkled on food or mixed with liquids.
Consumers and health care professionals are encouraged to report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/how.htm.
Cymbalta is manufactured by Indianapolis-based Eli Lilly and
For more information:
Shelly Burgess, 301-796-4651, firstname.lastname@example.org
Consumer Inquiries: 888-INFO-FDA
Posted: November 2010
- FDA Approves Cymbalta for Maintenance Treatment of Generalized Anxiety Disorder - November 30, 2009
- FDA Approves Cymbalta for the Management of Fibromyalgia - June 16, 2008
- FDA Approves Cymbalta for Maintenance Treatment of Major Depressive Disorder - November 30, 2007
- FDA Approves Cymbalta for Treatment of Generalized Anxiety Disorder - February 26, 2007
- FDA Approves Cymbalta for Neuropathic Pain Associated With Diabetes - September 7, 2004
- FDA Approves Cymbalta for the Treatment of Depression - August 4, 2004
- FDA Extends Action Date for Cymbalta for Continued Analysis of Already-Submitted Data - June 24, 2004