FDA warns Adolor of further delays for Entereg

USA-based drugmaker Adolor Corp says it has received notification from the US Food and Drug Administration that the agency will not be meeting the deadline it gave for the company to receive an action letter for Entereg (alvimopan), co-developed with UK giant GlaxoSmithKline.

The candidate has already been delayed by three months (Marketletter February 18), but the FDA says it expects to issue the action letter shortly. Last year, the future of the agent was called into question after a trial was terminated because of a high rate of adverse events (Marketletter April 16, 2007).

The New Drug Application under review is for 12mg capsules of Entereg for in-hospital, short-term use of the post-operative ileus drug. Specifically, it is for the acceleration of upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis.