Cubist seeks FDA sNDA approval for ENTEREG to accelerate GI recovery
Published on December 21, 2012 at 10:29 AM
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.
“Delayed GI recovery is one of the most common causes for prolonging hospital stay in patients undergoing surgeries that include a bowel resection”
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.
The most frequently reported treatment-emergent adverse events in the trial were hypokalemia, anemia, and postoperative ileus. The rate of postoperative ileus was 19.3% higher in the placebo-treated group compared to the ENTEREG-treated group. The incidence of all other treatment-emergent adverse events was comparable between the two groups. The majority of treatment-emergent adverse events were mild or moderate in severity. The incidence of severe treatment-emergent adverse events was comparable between the two treatment groups. In this study, blinded cardiovascular adverse events were adjudicated by an external independent clinical committee. The incidence of cardiovascular events was 15.3% percent for placebo-treated patients and 8.4% for ENTEREG treated patients, which was not statistically different.
Cubist Pharmaceuticals, Inc.