FDA OKs Postsurgical Drug for Hospital Use
Posted on: Wednesday, 21 May 2008, 09:01 CDT
The U.S. Food and Drug Administration announced approval of the drug Entereg (alvimopan) to help restore normal bowel function after surgery.
The FDA said it approved Entereg for use in hospitalized patients 18 years and older who have undergone partial large or small bowel resection surgery.
Patients who have undergone abdominal surgery and are on pain medications often experience problems eliminating waste, said Dr. Joyce Korvick, deputy director of the FDA's division of gastroenterology products. Entereg will help accelerate their recovery, improve bowel function and get these patients back on a normal diet.
The recommended dose for Entereg is one 12 milligram capsule given just prior to surgery and then another 12 mg dose administered twice daily for up to seven days, not to exceed 15 doses. The product will only be available in hospitals and will come in blister packs that are marked HOSPITAL USE ONLY.
Entereg is manufactured by the Adolor Corp. of Exton, Pa. The drug will be developed and marketed by Adolor and GlaxoSmithKline of London.
Source: United Press International
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