Eli Lilly withdraws Cymbalta application
Published: Sat, Nov. 29, 2008 12:30AM
Modified Sat, Nov. 29, 2008 01:41AM
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closeINDIANAPOLIS -- Drugmaker Eli Lilly and Co. withdrew an application to have its antidepressant Cymbalta approved as a treatment for chronic pain, but the company said Friday it will apply again in 2009.
Eli Lilly had filed a supplemental new drug application, asking the Food and Drug Administration to allow the company to market the drug for chronic pain. It plans to resubmit the data in the first half of 2009. The withdrawn applications included data from two trials in low back pain and one in chronic knee pain for osteoarthritis.
Lilly said FDA reviewers had questioned the effectiveness of the drug in chronic pain, pointing to issues related to the methodology and dosing of some of the trials. Cymbalta has been approved to treat depression, diabetic nerve pain and the pain disorder fibromyalgia.
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Cymbalta is Lilly's second best seller, after the anti-psychotic Zyprexa. In the first nine months of 2008, worldwide Cymbalta sales were $1.98 billion.
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