GSK suspends Entereg development
Executive Summary
Following a cardiovascular signal in a Phase III safety study of Entereg, GSK and Adolor are stopping development of alvimopan for treatment of opioid-induced bowel dysfunction, the companies say April 9. Similar to results from an interim analysis released in November, the study shows an increase in myocardial infarctions and all serious cardiovascular events for patients receiving alvimopan compared to placebo. However, the firms continue to pursue approval for a postoperative ileus indication that received an "approvable" letter in November...