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news.Array BioPharma has reported positive top-line results from a Phase II clinical trial evaluating the efficacy of ARRY-797, a novel, orally administered, small molecule pan-cytokine inhibitor, in patients with post-surgical dental pain.
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ARRY-797 achieved its primary and secondary endpoints for analgesic efficacy and was well tolerated. Based on these results, Array is moving forward with a second Phase II acute inflammatory pain trial comparing various doses of ARRY-797 to placebo and to celecoxib.
The analgesic effect of 400mg of ARRY-797, compared to placebo, was statistically significant based upon the primary endpoint of total pain relief over six hours post dose (p<0.0001). The analgesic effect was also statistically significant for total pain relief over three, eight, 12 and 24 hours post dose. Other analgesic endpoints, including total pain intensity, time to meaningful pain relief and time to analgesia were also significantly improved versus placebo. Peri-operative dosing with 200mg before and 200mg after surgery also resulted in a substantial reduction in total pain intensity.