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Lilly Resubmits Cymbalta(R) Supplemental New Drug Application for Chronic Pain to U.S. Food and Drug Administration
Date:6/3/2009

INDIANAPOLIS, June 3 /PRNewswire-FirstCall/ -- As projected, Eli Lilly and Company (NYSE: LLY) has resubmitted its supplemental New Drug Application (sNDA) for Cymbalta(R) (duloxetine HCl) for the management of chronic pain to the U.S. Food and Drug Administration (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 (DPNP) and fibromyalgia.

Lilly originally submitted the 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. At that time, Lilly said it expected to resubmit the application in the first half of 2009.

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

According to the International Association for the Study of Pain (IASP), pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage. (i) Chronic pain persists beyond acute pain or beyond the expected time for an injury to heal.(ii) Chronic pain disorders affect millions of Americans and can be a major cause of work absenteeism, underemployment and unemployment.

About Cymbalta

Based on preclinical studies,
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