Adolor Corporation and GlaxoSmithKline reported initial top-line results of the phase 3 study 14CL314 of Entereg (alvimopan) for the management of postoperative ileus (POI), by acceleration of the time to recovery of gastrointestinal (GI) function following bowel resection surgery.

According to the company release, the phase 3 study enrolled 654 patients scheduled to undergo large or small bowel resection surgery. The results showed that a 12 mg dose of the drug, Entereg, achieved a statistically significant difference compared to a placebo for the study's main goal of time to recovery of gastrointestinal function.

James Barrett, senior vice president, chief scientific officer and president, research of Adolor Corporation said, "We believe these data address the FDA's request for additional data outlined in the approvable letter received by Adolor in July of 2005. We intend to submit the final results from 314 as part of our complete response to the FDA by June of 2006."

The 634-patient study found a statistically significant benefit to the drug in the study's secondary goals, including time to hospital discharge.

Entereg was generally well tolerated in this study. The most frequently reported adverse events both in the alvimopan and placebo groups were nausea, vomiting and abdominal distention.

"Treatment with alvimopan significantly reduced the time required to recover GI function following bowel resection surgery. Furthermore, the alvimopan treatment group exhibited a significant reduction in complications related to POI," said Conor Delaney, professor and chief, division of colorectal surgery, vice-chairman, Department of Surgery of Case Western Reserve University, University Hospitals of Cleveland and an Investigator in the study.

"These outcomes, when taken together with the results of previous studies, represent meaningful benefit to patients and are likely to be an important step forward in the management of patients undergoing bowel resection surgery," added Delaney.

Adolor Corporation and GlaxoSmithKline are collaborating on the worldwide development and commercialization of Entereg for POI and the gastro-intestinal side effects of opioids associated with extended use for persistent pain.