An Advisory Committee of the Food and Drug Administration (FDA) has narrowly voted (8 to 6) in favor of expanding the indications for duloxetine HCl (Cymbalta™) to include chronic knee and low back pain. The Committee rejected (4 to 9, 1 abstention) the proposed indication for chronic pain due to osteoarthritis. Duloxetine is currently approved for major depressive and general anxiety disorders, the management of pain from diabetic peripheral neuropathy, and fibromyalgia. Although the FDA is not required to follow the recommendations of its committees in approving new medications or indications, it often follows the recommendations.

The Committee made its decision based on three studies that examined the efficacy and safety data that focused on chronic low back pain, as well as two new studies in chronic pain caused by osteoarthritis of the knee; they also went over the general safety data for the drug. All of the studies compared various doses of duloxetine with placebo.

In addition, the committee voted positively (9 to 4) regarding the overall safety profile of Cymbalta, including potential liver toxicity, with the majority agreeing that the benefit-risk profile warrants an expanded indication.

1. Center for Drug Evaluation and Research (CDER). Meeting of the Anesthetic and Life Support Drugs Advisory Committee (ALSDAC). Summary of NDA 22-516 Cymbalta for Chronic Pain. August 19, 2010. Food and Drug Administration [website]. Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndLifeSupportDrugsAdvisoryCommittee/UCM222701.pdfAccessed August 20, 2010.

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This entry was posted on Friday, August 20th, 2010 at 12:00 pm.