The companies were conducting the trial in an attempt to provide additional data to satisfy the FDA after the US regulators indicated in July last year that it would need more information on the drug before it could approve it.
In the study, which enrolled 654 patients scheduled to undergo large or small bowel resection surgery, the drug produced statistically significant acceleration in time to recovery of gastrointestinal function following bowel resection surgery.
“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 as part of our complete response to the FDA by June of 2006,” stated Dr James Barrett, senior vice president, chief scientific officer and president, research of Adolor Corporation.
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.