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FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
Date:11/30/2007

ned to either Cymbalta at the same dose or to a sugar pill for 6 months. Patients on Cymbalta experienced a statistically longer time to relapse of depression than did patients on placebo. Relapse was defined as an increase of two or more points on the Clinical Global Impression - Severity scale (CGI-S) compared with that obtained at week 12, and also meeting the criteria for major depressive disorder for two consecutive visits.

In this study, nausea was the most frequently reported side effect (also referred to as a treatment-emergent adverse event) during the acute phase and was reported as a reason for discontinuation for 2.1 percent of patients. In the continuation phase, there were no significant differences in reported side effects between patients taking Cymbalta compared with those taking sugar pills. Among patients who completed the first 12 weeks of the trial and entered the continuation phase, 3.6 percent reported side effects as reasons for discontinuation over the next 26 weeks (continuation phase) of the study.(2)

Cymbalta, a member of a class of drugs commonly referred to as serotonin and norepinephrine reuptake inhibitors (SNRI), has been studied in more than 27,000 patients worldwide. Cymbalta is already approved for the acute treatment of major depressive disorder, the management of diabetic peripheral neuropathic pain, and for the treatment of generalized anxiety disorder, all in adults. More than 9 million adults in the United States have been prescribed Cymbalta since approval.

About Cymbalta

Serotonin and norepinephrine in the brain and spinal cord are believed to both mediate mood symptoms of depression 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 duloxet
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SOURCE Eli Lilly and Company
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