02.08.06
Adolor Corp. and GlaxoSmithKline achieved initial top-line results of the Phase III Study 14CL314 of Entereg for the management of postoperative ileus (POI), by acceleration of the time to recovery of gastrointestinal (GI) function following bowel resection surgery. The study enrolled 654 patients scheduled to undergo bowel resection surgery. The results showed that a 12 mg dose of Entereg achieved a statistically significant difference compared to placebo for the primary endpoint, and for each of the secondary time to event endpoints, including time to discharge.
"We are exceptionally pleased by the robustness of the data in this study," stated James Barrett, Ph.D., senior vice president, chief scientific officer and president, research of Adolor Corp. "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."
"We are exceptionally pleased by the robustness of the data in this study," stated James Barrett, Ph.D., senior vice president, chief scientific officer and president, research of Adolor Corp. "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."
