Entereg® (Alvimopan): FDA-Approved for Post-Surgery Bowel Function

Filed in archive FDA Approvals , Treatment on May 23, 2008

The FDA has recently approved Entereg® (Alvimopan) for help to restore bowel function after surgery.

Entereg® (Alvimopan) is a first-in-class small molecule, peripherally-acting mu opioid receptor (PAM-OR) antagonist designed to block the adverse side effects of opioid analgesics on the GI tract without blocking their beneficial analgesic effects.

Entereg® (Alvimopan) is a product of Adolor Corporation in collaboration with GlaxoSmithKline.

Following major abdominal surgery, some patients develop a condition known as postoperative ileus (POI). POI is a disorder that causes temporary impairment of the gastrointestinal (GI) tract's motility, or the ability of the intestines to push out waste products (not a complete blockage of the GI tract), following surgery.

POI can be a by-product of a patient taking opioid pain relievers, like morphine, prescribed after surgery which can slow or inhibit normal motility. Entereg works by blocking opioid effects in the bowel.

The recommended dose for Entereg is one 12 milligram (mg) capsule given just prior to surgery and then another 12 mg dose administered twice daily for up to 7 days or not to exceed 15 doses. The product will only be available to hospitals and will come in blister packs that are marked "HOSPITAL USE ONLY." Entereg is not approved for use in pediatric populations.

More details from the FDA News.

[In Photo: Handbook of Opioid Bowel Syndrome (Hardcover) by Chun-Su, Ph.D. Yuan (Editor) from Amazon]