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news.Array BioPharma has commenced dosing ARRY-797, a novel, small molecule p38 inhibitor, in a randomized, double-blind, placebo-controlled, parallel-group Phase II trial to evaluate the efficacy of this drug for treating pain in dental patients undergoing third molar extraction.
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The objective of the study is to assess the safety, tolerability and analgesic efficacy of ARRY-797 dosed either after the operation or both before and after surgery. Although analgesics are typically administered with the onset of pain, emerging evidence suggests that dosing an anti-inflammatory drug prior to a surgical procedure can help block the development of pain. The trial will enroll 150 patients and be conducted at two centers in the US.
John Yates, chief medical officer, Array BioPharma, said: “I am delighted that we are now dosing patients in our Phase II study to evaluate the efficacy of ARRY-797 in the management of postoperative dental pain. We believe we are likely to see significant efficacy in acute pain based upon ARRY-797’s pharmacodynamic activities to date. This model has been a good predictor of acute analgesic effects of various pain medications.”