ADOLOR, GSK'S DRUG FOR POSTOPERATIVE ILEUS GETS APPROVABLE LETTER

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

The study is an ongoing Phase III, blinded, long-term safety study being 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 postoperative ileus included the six-month interim analysis of the study. This analysis was submitted in late September 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, and they 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 did not support a conclusion that patients taking alvimopan were at increased risk for serious cardiovascular events.