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FDA posts Cymbalta briefing documents

August 18, 2010 12:10 AM UTC

FDA posted briefing documents ahead of Thursday's Anesthetic and Life Support Drugs Advisory Committee meeting to discuss an sNDA from Eli Lilly and Co. (NYSE:LLY) for Cymbalta duloxetine to treat chronic pain. FDA said in the documents that the company has provided evidence for efficacy of the compound to treat chronic pain in patients with osteoarthritis and with chronic lower back pain. The agency also said that the mix and number of patient populations studied in the Cymbalta development program would be adequate to support the broadened indication. Cymbalta is already approved in the U.S. for diabetic peripheral neuropathic pain and fibromyalgia syndrome, as well as for generalized anxiety disorder (GAD) and major depressive disorder (MDD).

The agency's safety findings focused on Cymbalta's potential to cause hepatotoxicity, which is already mentioned on the drug's labeling. FDA reviewers disagreed whether the drug should receive a black box warning for hepatotoxicity. ...