FDA approves alvimopan (Entereg) for the treatment of post-operative ileus

June 16, 2008

GSK and Aldolor's alvimopan is approved to improve GI recovery following surgery.

Alvimopan (Entereg), a peripherally acting mu-opioid receptor antagonist from both Aldolor and GlaxoSmithKline, has been granted approval by the Food & Drug Administration to accelerate gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis. Alvimopan is for in-hospital use only and is used as a single 12-mg capsule administered orally prior to surgery followed by a capsule twice daily beginning the day after surgery for up to seven days, not to excced 15 total doses. The FDA will allow use of the drug only at hospitals registered under the Entereg Access Support and Education (E.A.S.E) program. The E.A.S.E. program is part of the Risk Evaluation and Mitigation Strategy (REMS) developed for alvimopan, which includes limits on dispensing of the drug.