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Duloxetine received a second FDA approval a month after it was approved for depression when it also became the first FDA-approved treatment for pain caused by diabetic peripheral neuropathy on September 7, 2004.[23] The approval was based on two clinical trials done by Eli Lilly between June 2001 and August 2003. At 20mg per day Cymbalta showed no clinical improvement over placebo. At 60mg per day Cymblata showed modest improvement for diabetic pain over baseline, with 51 percent of patients treated with Cymbalta reporting at least a 30 percent sustained reduction in pain. In comparison, 31 percent of patients treated with placebo reported this magnitude of sustained pain reduction. At 60mg per day 89.5% of patients had some marked treatment adverse effects in one trial, and 87% in the other trial.[24][25]
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