Adolor Corporation announced top-line results of its Phase 3 clinical study (14CL308) of Entereg (alvimopan) in the management of postoperative ileus (POI). Study 14CL308 enrolled 666 subjects who were scheduled to undergo large or small bowel resections, or simple or radical hysterectomy.

In the primary endpoint of study 14CL308, time to recovery of gastrointestinal function, a positive trend was observed when each of the Entereg 6 mg and 12 mg treatment groups was compared to the placebo group (Cox proportional hazard model: for 6 mg group, hazard ratio = 1.20, P = 0.079; for 12 mg group, hazard ratio = 1.24, P = 0.038).

A difference in favour of Entereg was observed for all of the secondary endpoints in both the 6 mg and 12 mg treatment groups. Statistically significant differences were achieved in time to hospital discharge order written in each of the 6 mg and 12 mg treatment groups as compared to the placebo group.

"We are pleased today to report results from Study 308," stated Bruce Peacock, president and CEO of Adolor. "Our four Phase 3 clinical trials enrolled more than 2,000 subjects, which we believe represents a very substantial clinical development programme. The completion of Study 308 supports our goal of submission of a New Drug Application for Entereg late in the first half of 2004."

Mean times to recovery of gastrointestinal function were approximately 8 hours and 10 hours sooner for each of the Entereg 6 mg and 12 mg treatment groups, respectively, as compared with the placebo group. Mean times to hospital discharge order written were approximately 14 and 15 hours sooner for each of the 6 mg and 12 mg treatment groups, respectively, as compared with the placebo group. For the approximately 437 subject subgroup of bowel resection subjects, mean times to hospital discharge order written were approximately 17 hours and 21 hours sooner for the 6 mg and 12 mg treatment groups, respectively, each as compared to the placebo group.

Entereg was generally well tolerated in this study. The most frequently observed adverse events in both the 6 mg and 12 mg treatment groups and the placebo groups were nausea, vomiting, and pruritus.