FDA Approves Entereg to Improve Post-Surgery Bowel Function

The FDA has approved Entereg® (alvimopan) to speed the restoration of normal bowel function after intestinal surgery.

However, the approval comes with a Risk Evaluation and Mitigation Strategy (REMS) to be sure that the benefits of using Entereg outweigh any potential risks.  Under the REMS, the drug can only be used only in hospitals for inpatients.  Hospitals that use it must be certified and materials developed for the health care professionals who administer it.  Its effectiveness must be regularly assessed.

One of the normal side effects of abdominal surgery is a temporary reduction in bowel activity.  The rhythmic forward motion of the intestinal muscles stops and body waste is not pushed out.  Normally, bowel function returns fairly soon after surgery, but some patients may experience a prolonged postoperative ileus. Opioid drugs used to manage pain can contribute to ileus and slow bowel recovery time.

Prolonged ileus can be uncomfortable, prevent eating or drinking and require IV’s, and keep patients in the hospital longer.

Entereg selectively blocks the action of opioids on the intestinal tract but not in the central nervous system.   So bowel activity isn’t affected, but postsurgical pain is controlled.

In a randomized, placebo-controlled study reported in the Annals of  Surgery in 2004, alvimopan shortened the time to bowel recovery by 22 hours.  Bowel recovery was measured when patients could tolerate a solid diet or had a bowel movement or passage of gas.  Patients were discharged from the hospital 20 hours sooner.  The study found no difference in postoperative pain.

Good news for patients was that alvimopan reduced the percentage of them who needed an uncomfortable nasogastric tube inserted after their surgery from 15 percent to 5 percent.

Patients receive one 12 mg capsule of Entereg two hours before surgery, and additional 12 mg capsules twice a day for up to seven days after surgery.  FDA approved dose is limited to 15 capsules, to be given in the hospital only,

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