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Lilly Submits Cymbalta(R) Supplemental New Drug Application for Chronic Pain to U.S. Food and Drug Administration
Date:5/29/2008

INDIANAPOLIS, May 29 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE: LLY) has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval for a new indication for Cymbalta(R) (duloxetine HCl) for the management of chronic pain, the company announced today. The submission is based on outcomes of clinical trials in chronic osteoarthritis pain of the knee and chronic low back pain, in addition to data from previously completed pain studies in diabetic peripheral neuropathic pain (DPNP) and fibromyalgia. Cymbalta was studied in chronic pain of at least moderate severity in adults who required daily treatment for an extended period of time.

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)

About Cymbalta

Serotonin and norepinephrine in the brain and spinal cord are believed to both mediate core mood symptoms and help regulate the perception of pain. Based on pre-clinical studies, Cymbalta is a balanced and potent reuptake inhibitor of serotonin and norepinephrine that is believed to potentiate the activity of these chemicals in the central nervous system (brain and spinal cord). While the mechanism of action of Cymbalta is not fully known, scientists believe its effects on depression and anxiety symptoms, as well as its effect on pain perception, may be due to increasing the activity of serotonin and norepinephrine in the central nervous system.

Cymbalta is approved in the United States for the
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SOURCE Eli Lilly and Company
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