Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that it has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (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.
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. This study, in conjunction with the original clinical trial data, forms the body of evidence supporting the request for expansion of the current indication.
“Delayed GI recovery is one of the most common causes for prolonging hospital stay in patients undergoing surgeries that include a bowel resection,” said Cubist’s Chief Scientific Officer Steve Gilman, PhD. “This submission is an important achievement for Cubist and we look forward to working with the FDA as they evaluate this application.”
Radical Cystectomy Phase 4 Study Design and Key Findings
The radical cystectomy study, a post-approval commitment with the FDA, investigated ENTEREG 12mg or placebo administered by mouth once preoperatively and twice daily (BID) postoperatively for a maximum of 15 hospital doses in 280 patients undergoing radical cystectomy. Assessments for efficacy were performed over a 10-day observation period and safety was evaluated through a 30-day period after the last dose of the study drug.
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 1.0 days shorter, respectively, compared to patients receiving placebo (p=0.005).