- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
FDA Approves Expanded Use of Entereg (Alvimopan) Following GI Surgeries
Drug is available only for short-term use in hospitalized patients (October 21)
The FDA has approved a supplemental new drug application (sNDA) for Entereg (alvimopan, Cubist Pharmaceuticals). The approval expands the drug’s current indication to accelerate the time to upper and lower gastrointestinal (GI) recovery following surgeries that include partial bowel resection with primary anastomosis.
The agency’s decision was primarily based on the results from a phase IV randomized, placebo-controlled, double-blind trial involving patients undergoing radical cystectomy, an extensive surgical procedure that includes resecting a segment of the bowel to reconstruct the lower urinary tract. The drug’s original indication was supported by trials in patients undergoing bowel resection for benign or malignant colorectal or small-bowel disease.
Entereg (alvimopan) is a peripherally acting mu-opioid receptor antagonist. It was originally approved in the U.S. in 2008.
Because of concerns that long-term use of alvimopan may be associated with an increased risk of myocardial infarction, Entereg is available only for short-term use (15 doses) in hospitalized patients.
Source: Cubist Pharmaceuticals; October 21, 2013.