News & Events

FDA NEWS RELEASE

For Immediate Release: Nov. 4, 2010

Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

FDA clears Cymbalta to treat chronic musculoskeletal pain

Indications include osteoarthritis, chronic lower back pain

The U.S. Food and Drug Administration today approved Cymbalta (duloxetine hydrochloride) to treat chronic musculoskeletal pain, including discomfort from osteoarthritis andchronic lower back pain. Cymbalta was first used to treat major depressive disorder in 2004.

“Upto 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.”

Sinceits 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 reviewof 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 sideeffects include liver damage, allergic reactions suchas hives,rashes and/or swelling of the face, pneumonia, depressed mood, suicide,s uicidal thoughts and behavior.

While these serious side effects have been associated with theuse of Cymbalta, they have occurred in less than 1% of treated patients. There area finite number of drugs available for the treatment of chronic musculoskeleta 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 onfood or mixed with liquids.

Consumers and health care professionals are encouraged to report adverse events tothe FDA's MedWatch programat 800-FDA-1088 or online at www.fda.gov/medwatch/how.htm13.

Cymbalta is manufactured by Indianapolis-based Eli Lilly and Co.