The FDA announced Thursday that it approved Eli Lilly's antidepressant Cymbalta (duloxetine) as a treatment for patients with chronic musculoskeletal pain, including discomfort from osteoarthritis and chronic lower back pain. The approval marks the first "non-traditional analgesic" approved for chronic pain.

The agency said that it assessed the efficacy of Cymbalta in chronic low back pain and osteoarthritis in four randomised clinical trials. Results showed that at the end of the study period, patients taking the product had a significantly greater pain reduction compared with placebo.

 The FDA noted that there are a "finite" number of drugs available for the treatment of chronic musculoskeletal pain, all of which carry side effects."There are patients in whom none of the available treatments are effective," the agency explained, adding that serious side effects have occured in less than 1 percent of patients receiving Cymbalta.

Leerink Swann & Co. analyst Seamus Fernandez, said that approval for the drug in this indication may increase sales for Cymbalta by only $500 million since "half of that market opportunity could already be potentially accounted for," with previous off-label prescribing.

 

Sales of Cymbalta, which is also approved to treat diabetic nerve pain, fibromyalgia and anxiety, were just over $3 billion last year.

 

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