New drug to restore bowel function approved under new FDA rules

摘要

FDA approved a new drug on May 20 to help restore normal bowel function after some types of abdominal surgery under new rules that allow several safety-related restrictions.rnThe drug, to be marketed as Entereg, is indicated for use in hospitalized patients 18 years or older who have undergone partial large or small bowel resection surgery. Under FDA's new Risk Evaluation and Mitigation Strategy (REMS) rules, the product may be given only to inpa-tients at specially certified facilities.rnAdolor Corporation manufactures the drug, which has the generic name alvimopan and is a peripherally acting μ-opioid-receptor antagonist, according to the Exton, Pennsylvania, company.rnFDA says patients may not receive more than 15 doses of the product. The drug agency states that it is approving Entereg with REMS restrictions to makernsure the drug's benefits outweigh the risks.