GSK/Adolor Entereg approvable again
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
GlaxoSmithKline and Adolor plan to continue development of Entereg (alvimopan) after the NDA for management of post-operative ileus was deemed "approvable" a second time, the companies said Nov. 6. FDA noted a potential increased risk of cardiovascular events and requested additional 12-month safety data from GSK's ongoing Phase III safety study (76905/014) in opioid-induced bowel dysfunction in chronic cancer pain patients, as well as a risk management plan. The first approvable letter, issued in July 2005, requested additional efficacy data in patients following bowel resection surgery (1Pharmaceutical Approvals Monthly February 2006, p. 9). The response to the first approvable letter was submitted in May 2006; a response to the second letter appears unlikely before the second quarter of 2007, when final data from the 014 study is expected...