Adolor Corporation and GlaxoSmithKline (GSK) announced that the US Food and Drug Administration (FDA) has informed Adolor that the Prescription Drug User Fee Act action date for the New Drug Application (NDA) for Entereg (alvimopan) has been extended to May 10, 2008. Adolor also announced the submission to the FDA of a revised Risk Management Programme for Entereg.

The NDA for Entereg 12 mg capsules is for in-hospital, short-term use for the management of postoperative ileus (POI). Specifically, the proposed indications are for the acceleration of upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis. There are no other FDA approved drugs for this indication.

"Earlier this week, we submitted to the FDA a revised risk management programme for Entereg," said Michael R Dougherty, president and chief executive officer of Adolor Corporation. "We believe the programme provides appropriate measures to ensure that Entereg is used in patients for whom it has demonstrated a favourable benefit/risk profile. We look forward to working with the FDA as it completes its review of our NDA."

Adolor Corporation is a biopharmaceutical company specializing in the discovery, development and commercialization of novel prescription pain management products. Adolor has two lead product candidates in development: Entereg (alvimopan) for the management of the gastrointestinal side effects associated with opioid use; and novel Delta opioid receptor agonists for a variety of pain indications. Adolor and GlaxoSmithKline are collaborating in the worldwide development and commercialization of Entereg in multiple indications. Adolor and Pfizer are collaborating in the worldwide development and commercialization of two Delta agonists for pain.