FDA approves agent to help restore bowel function after surgery

May 21, 2008

FDA granted approval yesterday to alvimopan (Entereg), a drug that accelerates the restoration of normal bowel function in patients 18 years and over who have undergone partial large or small bowel resection surgery. Alvimopan will be used in hospitalized patients, who can receive no more than 15 doses.

FDA granted approval yesterday to alvimopan (Entereg), a drug that accelerates the restoration of normal bowel function inpatients 18 years and over who have undergone partial large or small bowel resection surgery. Alvimopan will be used in hospitalized patients, who can receive no more than 15 doses.

Postoperative ileus can be a by-product of a patient taking opioid pain relievers prescribed after surgery, which can slow orinhibit normal motility. Alvimopan works by blocking opioid effects in the bowel. Recommended dosage is one 12-mg capsulegiven just prior to surgery, and a second 12-mg dose administered twice daily for up to 7 days, up to a total of 15doses.

FDA is approving the drug with a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drugoutweigh the risks. The REMS will include limits on dispensing of the drug.

The REMS will include restricting alvimopan to inpatient use only, requiring that hospitals be specially certified,distribution of educational materials to health care professionals, and regular assessments of the effectiveness of theREMS.

The drug will only be available to hospitals.