FDA May Approve Cymbalta for Low Back Pain

September 23rd, 2010 | Sources: Wall Street Journal

Last week, an FDA advisory panel narrowly supported a proposal by Eli Lilly & Co. to approve its blockbuster antidepressant Cymbalta for the treatment of chronic lower back pain.

Cymbalta has already been approved to treat fibromyalgia, anxiety and diabetic nerve pain. The drug is Lilly’s top-seller, having rung-up more than $3 billion in sales last year.

Before the vote, the committee reviewed FDA data showing that 2/3 of Cymbalta prescriptions written last year were for off-label uses, including headaches, musculoskeletal pain and non-diabetic nerve pain.

Regarding Lilly’s current proposal, 8 of the 14 members on the FDA’s anesthetic and life support drugs advisory committee voted “yes” in response to a question whether the FDA should green-light Cymbalta for the treatment of pain in a “broader population” than that which it has already approved.

The panel clarified that the FDA should approve Cymbalta for lower back pain but not for pain associated with osteoarthritis of the knee. In support of its decision, the panel noted that 2 out of 3 Lilly-funded studies of people with low back pain showed that Cymbalta provided significant pain relief over a 3-month period. In the case of osteoarthritis, only one out of two studies showed the drug reduced pain.

The FDA is not required to follow recommendations of its advisory committees, but it usually does.

Cymbalta carries a black-box warning from the FDA regarding the risk of suicide in children, adolescents and young adults. There are also warnings about liver damage, bleeding and adverse effects on blood pressure.


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