The US Food and Drug Administration (FDA) has approved Cubist Pharmaceuticals' supplemental new drug application (sNDA) Entereg (alvimopan). The sNDA approval expands the indication for the use of Entereg to accelerate the time to upper and lower gastrointestinal (GI) recovery following surgeries that include partial bowel resection with primary anastomosis (i.e., re-connection of the bowel following removal of the resected segment).
Primary support for this expansion was a phase IV randomized, placebo-controlled, double-blind trial in patients undergoing radical cystectomy, an extensive surgical procedure that includes resecting a segment of the bowel to reconstruct the lower urinary tract. The original indication was supported by trials in patients undergoing bowel resection for benign or malignant colorectal or small bowel disease.
“Delayed GI recovery is one of the most common causes of prolonged hospital stays in patients undergoing major abdominopelvic surgery. We are pleased that doctors will have the option to help speed GI recovery for appropriate patients who have undergone surgeries that included a bowel resection,” said Steven Gilman, executive vice president of Research and Development and chief scientific officer of Cubist Pharmaceuticals. “At Cubist, we are committed to improving patient outcomes within the hospital setting, and enabling patients to leave the hospital sooner through the use of therapeutics that help put them on the path to good health.”
The FDA originally approved Entereg in 2008 to accelerate the time to upper and lower GI recovery following partial large or small bowel resection surgery with primary anastomosis. To date, Entereg is the first and only FDA-approved agent for this use.
Entereg was approved in the United States in 2008. It is a peripherally acting µ-opioid receptor antagonist indicated to accelerate the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection with primary anastomosis.
Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on the research, development, and commercialization of pharmaceutical products that address significant unmet medical needs in the acute care environment.