FDA extends review of NDA for Entereg, say Adolor and GSK

The NDA for Entereg 12mg capsules is for in-hospital, short-term use for the management of postoperative ileus (POI). Specifically, the proposed indication is for the acceleration of upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis. Adolor also announced the submission to the FDA of a revised Risk Management Program for Entereg.

Michael Dougherty, president and CEO of Adolor, said: “We believe the program provides appropriate measures to ensure that Entereg is used in patients for whom it has demonstrated a favorable benefit to risk profile. We look forward to working with the FDA as it completes its review of our NDA.”