Eli Lilly ($LLY) has finally caught a break. The company won a coveted indication for its blockbuster antidepressant Cymbalta, as a treatment for chronic musculoskeletal pain. That includes osteoarthritis pain and lower back pain--two incredibly common problems. As the FDA's Janet Woodcock notes in a statement, "Up to three quarters of the population experience chronic pain at some time in their lives."
Data supporting Cymbalta for pain relief came from four clinical trials, which showed Cymbalta patients experiencing "significantly greater" pain relief compared with placebo, the FDA says. When FDA advisory panelists reviewed the new indication in August, they agreed that Cymbalta was effective at treating chronic pain in some patients, Reuters reports. But they voted against recommending it as an arthritis treatment (4-9), and the vote on back pain was hardly unanimous (8-5).
Nonetheless, FDA granted the broad new indication, and Lilly will now get the chance to turn the marketing approval into actual sales. Cymbalta is already a major seller for Lilly with $3.5 billion in sales and is already used off-label to treat pain in some patients. FDA data showed that 7 percent of Cymbalta's prescriptions last year were for musculoskeletal diseases including arthritis and back pain. "Half of that market opportunity could already be potentially accounted for," Leerink Swann's Seamus Fernandez tells Bloomberg.
Still, Lilly can now promote the use to the millions upon millions of people with arthritis pain or lower-back pain. It will have to hurry to reap the full benefit of the new use: Cymbalta goes off patent in 2013. Fernandez estimates annual sales of Cymbalta may increase by $500 million, or 16 percent, with the new approval.