Lilly resubmits supplemental new drug application for pain drug

Thu. June 04, 2009; Posted: 01:15 PM

Jun 04, 2009 (Datamonitor via COMTEX) -- LLY | Quote | Chart | News | PowerRating -- Eli Lilly and Company has resubmitted its supplemental new drug application for Cymbalta for the management of chronic pain to the FDA.

Lilly's resubmission is based on a recently completed study in chronic pain due to osteoarthritis, the extension phase of a chronic low back pain study and previously completed studies in pain due to osteoarthritis and chronic low back pain. The application is supported by studies in diabetic peripheral neuropathic pain and fibromyalgia.

Lilly has originally submitted the supplemental new drug application (sNDA) in the second quarter of 2008 but withdrew the application in November 2008 following discussions with the FDA primarily about statistical methodology and study design.

John Hayes, vice president of Lilly Research Laboratories, said: "The additional chronic osteoarthritis pain and chronic low back pain data were not available at the time of the initial submission. We believe including these new data in the updated sNDA package will provide a broader clinical basis for the FDA to review the application."

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For full details on Eli Lilly & Company (LLY) click here. Eli Lilly & Company (LLY) has Short Term PowerRatings of 5. Details on Eli Lilly & Company (LLY) Short Term PowerRatings is available at This Link.

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