Cubist Pharmaceuticals announced that it has submitted a supplemental new drug application (sNDA) to the FDA requesting approval for the use of Entereg (alvimopan) to accelerate GI recovery following any surgery that includes a bowel resection with primary anastomosis; expanded from the current indication in patients requiring surgery for colorectal disease. Entereg is a peripherally acting µ-opioid receptor antagonist.
This proposed label modification is derived from a recently completed randomized, double-blind, placebo-controlled, Phase 4 clinical trial of patients undergoing radical cystectomy for bladder cancer, an extensive surgical procedure that includes resecting a segment of bowel to reconstruct the lower urinary tract. The study, a post-approval commitment with the FDA, investigated Entereg 12mg or placebo administered by mouth once preoperatively and twice daily postoperatively for a maximum of 15 hospital doses in 280 patients undergoing radical cystectomy. For the primary endpoint, Entereg accelerated upper and lower GI recovery compared to placebo (hazard ratio=1.8, P<0.0001). The mean and median time to achieve GI recovery was 1.3 days and 1.2 days earlier, respectively, in patients receiving Entereg compared to placebo. The mean and median postoperative hospital length of stay for patients receiving Entereg was 2.6 and 1 days shorter, respectively, compared to patients receiving placebo (P=0.005).
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