Entereg advisory committee

Executive Summary

FDA's Gastrointestinal Drugs Advisory Committee will review the NDA for GlaxoSmithKline/Adolor's µ-opioid receptor agonist Entereg for treatment of postoperative ileus following partial or small bowel resection surgery with primary anastomosis Jan. 23, 2008. The meeting will likely address a cardiovascular safety signal identified in a Phase III study, which led to the suspension of development of the new molecular entity for opioid-induced bowel dysfunction (1"The Pink Sheet" April 16, 2007, In Brief). The postoperative ileus indication for Entereg (alvimopan), which has received two "approvable letters," has a Feb. 10, 2008, user fee date...