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This is a revised version of FDA Press Release P04-87, originally issued September 7, 2004.
Revisions have been made to the data in paragraph four and the side effects in paragraph five.

FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
P04-87
September 7, 2004

Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA

FDA Approves Drug for Neuropathic Pain Associated With Diabetes

Today the Food and Drug Administration (FDA) announced the approval of Cymbalta (duloxetine hydrochloride) capsules for the management of the pain associated with diabetic peripheral neuropathy. This is the first drug specifically approved for this indication. Cymbalta received a priority review.

"Diabetes affect millions of Americans," said Dr. Lester M. Crawford, Acting FDA Commissioner. "With this new treatment we will hopefully be able to help relieve the pain associated with this terrible disease."

Diabetic peripheral neuropathy is a problem associated with long standing diabetes or poor glucose control. Peripheral neuropathy is the most common complication of diabetes mellitus, affecting up to 62% of Americans with diabetes. Diabetic peripheral neuropathy can manifest in a variety of ways but is usually characterized by burning, tingling, and numbing sensations beginning in the feet, and later affecting the legs and/or hands.

The safety and effectiveness of Cymbalta were established in two randomized, controlled studies of approximately 1074 patients. Although the mechanism of action is unknown, patients treated with Cymbalta reported a greater decrease in pain compared to placebo. In these trials, 51 percent of patients treated with Cymbalta reported at least a 30 percent sustained reduction in pain. In comparison, 31 percent of patients treated with placebo reported this magnitude of sustained pain reduction.

The most commonly reported side effects were nausea, somnolence, dizziness, decreased appetite, and constipation. In some cases, patients experienced dizziness and hot flashes.

Cymbalta is manufactured by Eli Lilly and Company in Indianapolis, Ind.

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