FDA OKs duloxetine hydrochloride to treat chronic musculoskeletal pain

FDA has cleared duloxetine hydrochloride (Cymbalta, Eli Lilly and Co.) to treat chronic musculoskeletal pain, including discomfort from osteoarthritis and chronic lower back pain, giving patients with such conditions another treatment option.

FDA assessed the efficacy of duloxetine hydrochloride in chronic low back pain and osteoarthritis in 4 double-blind, placebo-controlled, randomized clinical trials. Patients taking duloxetine hydrochloride had a significantly greater pain reduction compared with placebo, the agency announced.

More than 29,000 patients have used duloxetine hydrochloride in clinical trials, and more than 600 patients were studied in the clinical trials involving osteoarthritis and chronic low back pain.

Duloxetine hydrochloride was first used to treat major depressive disorder in 2004. 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.