FDA c'ttee gives nod to Adolor/GSK's Entereg

USA-based Adolor Corp and UK drug major GlaxoSmithKline say that a majority of the Gastrointestinal Drugs Advisory Committee of the US Food and Drug Administration voted that the overall benefits of treatment with Entereg (alvimopan), an investigational mu-opioid receptor antagonist, outweighed potential risks for short-term, in-hospital use in patients following partial large or small bowel resection surgery with primary anastomosis.

The FDA is reviewing Adolor's New Drug Application for the agent as a means of accelerating upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis. There are no drugs approved for this indication. The Committee's recommendation, although not binding, will be considered by the FDA as it completes its review of the NDA. A decision is expected on February 10. With regard to the specific questions posed by the FDA to the committee, members voted 13-0, with two abstentions, that the efficacy results from the submitted studies in postoperative ileus were clinically meaningful.