Cubist Pharmaceuticals announced that the FDA has approved the use of Entereg (alvimopan) to accelerate the time to upper and lower gastrointestinal (GI) recovery following surgeries that include partial bowel resection with primary anastomosis (eg, re-connection of the bowel following removal of the resected segment).

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Entereg is an opioid receptor antagonist that antagonizes the peripheral effects of opioids on GI motility and secretion by competitively binding to GI tract µ-opioid receptors.

The FDA approval is based on data from a Phase 4 randomized, placebo-controlled, double-blind trial that evaluated the safety and efficacy of Entereg in patients undergoing radical cystectomy, including resection of a bowel segment to reconstruct the lower urinary tract.

Entereg was originally approved in 2008 to accelerate the time to upper and lower GI recovery after partial large or small bowel resection surgery with primary anastomosis.

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