Adolor Corporation and GlaxoSmithKline, announced that the US Food and Drug Administration (FDA) has issued a letter stating that the new drug application (NDA) for Entereg (alvimopan 12mg) for the management of postoperative ileus (POI) is approvable. The FDA has requested 12-month safety data, including analysis of serious cardiovascular events, from study 767905/014, an ongoing safety study in opioid-induced bowel dysfunction (OBD). The FDA also requested a risk management plan as part of the submission.

Study 014 is an ongoing phase 3, blinded, long term (12 month) safety study conducted by GSK evaluating alvimopan 0.5 mg twice daily for the treatment of opioid-induced bowel dysfunction in patients with chronic non-cancer pain. The study is targeted for completion late in the first quarter of 2007, with final data available in the second quarter.

The FDA's review of the NDA for POI included the six-month interim analysis of study 014. This analysis was submitted in late September 2006 and showed an increase, which was not statistically significant, in the reported incidence of serious cardiovascular adverse events in patients receiving alvimopan relative to placebo. The reported events were in patients at high risk for cardiovascular disease, did not appear to be linked to duration of dosing and were consistent with epidemiological expectations for the subject population. Combined results from all completed studies in the chronic population submitted by GSK to the FDA did not support a conclusion that patients taking alvimopan were at increased risk for serious cardiovascular events.

"We will meet with the FDA to discuss the approvable letter and work with GSK to provide the additional information requested as expeditiously as possible," said David Madden, interim president and chief executive officer of Adolor.

"We continue to believe that Entereg has significant potential to benefit patients at risk of developing POI and those suffering from OBD and remain committed to its continued development," said Yvonne Greenstreet, senior vice president, R&D, GlaxoSmithKline.