Adolor Corporation announced top-line results of its first Phase 3 clinical study (14CL302) for its novel product candidate, alvimopan, in the management of postoperative ileus (POI).
A statistically significant difference was achieved in the primary endpoint of the study, time to recovery of gastrointestinal function, in patients in the alvimopan 6 mg treatment group compared to patients in the placebo group (Cox proportional hazard model; hazard ratio = 1.47; P<0.01). Time to recovery of gastrointestinal function was a composite measure of the time to recovery of both lower and upper gastrointestinal function as defined by time to first flatus or first bowel movement and time to tolerability of solid foods, whichever occurred last. A difference in favor of the alvimopan 6 mg treatment group versus placebo was observed for all secondary endpoints, including time to hospital discharge order written. A positive trend was observed in the primary endpoint of the study for the alvimopan 12 mg treatment group; however, the difference from placebo was not statistically significant (Cox proportional hazard model, hazard ratio = 1.23; P = 0.11).
Alvimopan was generally well tolerated in this study. The most frequently observed adverse events in both the placebo and treatment groups were nausea, vomiting and hypotension.
"We are delighted to have completed a major milestone in our alvimopan Phase 3 clinical program in postoperative ileus. We believe the results of this study support our goal of submitting a New Drug Application for alvimopan in 2003. We look forward to completing the accrual of our additional alvimopan postoperative ileus clinical studies, which will need to confirm the results of the 302 study in order to file a New Drug Application," commented Bruce A. Peacock, President and Chief Executive Officer of Adolor.
Study 14CL302 was a double-blind, placebo-controlled, multi-centered study that enrolled approximately 450 patients who were scheduled to undergo partial colectomies, simple or radical hysterectomies and to receive opioid analgesics. Patients were randomized in three arms of 150 each to receive placebo, 6 mg or 12 mg doses of alvimopan, at least two hours prior to surgery, and then twice a day beginning on the first postoperative day until hospital discharge or for a maximum of seven days postoperative treatment. The primary endpoint of the study was a composite measure of the time to recovery of both lower and upper gastrointestinal function as defined by time to first flatus or first bowel movement and time to tolerability of solid foods, whichever last occurred.