The US Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for the mu-opioid receptor antagonist alvimopan (Entereg, Cubist Pharmaceuticals).
The FDA originally approved alvimopan in 2008 to accelerate the time to upper and lower gastrointestinal (GI) recovery following partial large- or small-bowel resection with primary anastomosis.
The sNDA expands the indication to accelerate the time to upper and lower GI recovery following surgeries that include partial bowel resection with primary anastomosis, the company notes in a news release.
"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," Steven Gilman, PhD, executive vice president of research and development and chief scientific officer of Cubist Pharmaceuticals, said in the release.
The expanded indication was based largely on a phase 4 randomized, placebo-controlled, double-blind trial in patients undergoing radical cystectomy, the company said. The original indication was supported by trials in patients undergoing bowel resection for benign or malignant colorectal or small-bowel disease.
Because of the potential risk for myocardial infarction with long-term use, alvimopan is available only for short-term use (15 doses) through a risk evaluation and management strategy (REMS) program, a boxed warning notes.
Alvimopan is contraindicated in patients who have taken therapeutic doses of opioids for more than 7 consecutive days immediately before taking alvimopan, and the drug should be administered with caution to patients receiving more than 3 doses of an opioid within the week prior to surgery, the company notes.
Alvimopan is not recommended for use in patients with severe hepatic impairment, end-stage renal disease, complete GI obstruction, or pancreatic or gastric anastomosis or in patients who have had surgery for correction of complete bowel obstruction.
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Cite this: FDA OKs Expanded Use of Alvimopan (Entereg) - Medscape - Oct 24, 2013.