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ARTICLE | Clinical News

Iroko reports Phase III data for submicron diclofenac

April 12, 2013 11:54 PM UTC

Iroko Pharmaceuticals LLC (Philadelphia, Pa.) said thrice-daily lower dose submicron diclofenac met the primary endpoint of reducing mean WOMAC pain subscale scores from baseline to week 12 vs. placebo in a Phase III trial to treat osteoarthritis (OA) pain (44.1 vs. 32.5 point reduction, p=0.0024). A twice-daily dose of submicron diclofenac missed the endpoint (39 point reduction, p=0.0795). The double-blind trial enrolled 305 patients with OA of the hip or knee. Data will be presented at the World Congress on Osteoarthritis in Philadelphia this month. ...