New Data Suggest Cymbalta(R) Reduced Pain in Fibromyalgia Patients With and Without ...('getLinkName('Company Sanpshot')); LLY ...),Health

Date:8/21/2007

',getLinkName('Company Sanpshot'));" >LLY) also announced today that it recently submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for Cymbalta for the management of fibromyalgia. The sNDA submission is based on data from approximately 1,400 patients in five clinical trials.

"Lack of awareness of fibromyalgia can lead to frustration as patients often see multiple physicians over a number of years before receiving a formal diagnosis," said Alan Breier, M.D., vice president for medical and chief medical officer, Eli Lilly and Company. "This research may help increase recognition of fibromyalgia and offer hope to those living with this debilitating condition."

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, duloxetine 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 duloxetine 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 treatment of major depressive disorder (MDD), the management of diabetic peripheral neuropathic pain (DPNP) and the treatment of generalized anxiety disorder (GAD), all in adults (age 18+). Cymbalta is not approved for use in pediatric patients.

Important Safety Information

Cymbalta is approved to treat major depressive disorder and generalized anxiety disorder and manage diabetic peripheral neuropathic pain. Antidepressants can increase suicidal thoughts and behaviors in children, adolescents and young adults. Pati
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SOURCE Eli Lilly and Company Copyright©2007 PR Newswire.

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