Adolor and GSK publish Ph III Entereg results

USA-based Adolor Corp and UK drug major GlaxoSmithKline have published the results of a Phase III study of their peripherally-acting mu-opioid receptor antagonist Entereg (alvimopan), for the management of postoperative ileus, in the Archives of Surgery.

The study was a multicenter, randomized, placebo-controlled, double-blind trial, investigating the efficacy and safety of Entereg in conjunction with a standardized accelerated postoperative care pathway (early ambulation, oral feeding and postoperative nasogastric tube removal) for managing POI following bowel resection surgery. The study enrolled 654 bowel-resection patients, randomized into two arms to receive either placebo or 12mg of Entereg twice daily. Entereg accelerated the time to recovery of GI function and reduced the time to hospital discharge order written as compared to placebo.