Cubist Pharmaceuticals' Entereg (alvimopan) has met the primary endpoint of time to achieve recovery of both upper and lower gastrointestinal (GI) function and secondary endpoints, including length of hospital stay, in the Phase 4 study.
The FDA-approved Entereg is a peripherally acting u-opioid receptor antagonist indicated to accelerate the time to upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis.
The Phase 4 randomised double-blind placebo-controlled study administered Entereg 12mg or placebo once preoperatively and twice daily (BID) postoperatively for a maximum of 15 hospital doses in 280 patients undergoing radical cystectomy.
The efficacy assessments were performed over a ten day observation period and safety evaluated through 30 days after the last dose of the study drug.
In the study, the median time to achieve GI recovery was found to be 1.2 days and mean and median postoperative hospital length of stay for patients was 2.6 and 1.0 days shorter, respectively, in patients receiving Entereg compared to placebo.
Cubist Pharmaceuticals Research and Development executive vice president Steven Gilman said the accelerated recovery of GI function and associated reduction in length of stay suggests that Entereg has the potential to improve surgical outcomes for patients undergoing radical cystectomy.
"We are very excited about these clinical trial results, look forward to discussing these data with the FDA, and expect to submit a supplemental New Drug Application by the end of 2012," Gilman added.
The treatment-related adverse events included hypokalemia, anemia and postoperative ileus, and the incidence of cardiovascular events was 15% for placebo-treated patients compared to 8.4% for Entereg-treated patients.
The estimated number of new cases of bladder cancer in 2012 is projected to be 73,000, with approximately 15,000 deaths, according to the National Cancer Institute.