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Lilly Cymbalta keeps growing in pain states

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA approval of Lilly's Cymbalta (duloxetine) for management of fibromyalgia June 16 comes on the heels of a May sNDA submission for management of chronic pain that is backed by the same trial data that supported the fibromyalgia filing. Lilly also submitted chronic pain data from three additional trials, two in chronic low back pain and one in osteoarthritis of the knee. OA of the knee data from a 231-patient trial that Lilly characterized as "the first time duloxetine has been studied in a large, placebo-controlled trial in … an inflammatory disease state" was presented to the European League Against Rheumatism annual congress in Paris June 13. On the primary efficacy measure of mean 24-hour pain score, 59 percent of duloxetine OA of the knee patients reported a 30 percent improvement in pain compared with 45 percent of placebo patients; a 50 percent improvement in pain was reported by 47 percent of duloxetine and 29 percent of placebo patients. The serotonin and norepinephrine reuptake inhibitor's expansion from its core antidepressant use was inaugurated by a diabetic neuropathic pain claim approved Sept. 3, 2004

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