FDA clears drug used to treat depression for chronic musculoskeletal pain

The FDA recently approved duloxetine hydrochloride to treat chronic musculoskeletal pain, including discomfort from osteoarthritis and chronic lower back pain, according to an FDA press release.

Duloxetine hydrochloride (Cymbalta, Eli Lilly and Co.) was first used as a treatment for major depressive disorder in 2004.

“Up to three quarters of the population experience chronic pain at some time in their lives,” Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research, stated in the release. “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. The drug has been approved to treat other conditions such as diabetic peripheral neuropathy, generalized anxiety disorder and fibromyalgia.

According to the release, more than 29,000 patients have used Cymbalta in clinical trials. Investigators studied more than 600 patients in the clinical trials involving osteoarthritis and chronic low back pain. To evaluate the safety of Cymbalta, data from the clinical trials as well as post-marketing data from the previously-approved patient populations were reviewed.

The FDA assessed the efficacy of the drug for chronic low back pain and osteoarthritis using four level 1 clinical trials, according to the release. At the conclusion of the study period, investigators found that patients taking Cymbalta had a significantly greater pain reduction compared with placebo.

According to the FDA release, 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. These serious side effects occurred in less than 1% of the treated patients.