Adolor submitted a new drug application to the FDA for Entereg in June 2004, but in July of this year the FDA informed the company that it would need more information on the drug before it could be approved.
In this pivotal trial patients were randomized to receive either 12 mg of Entereg or placebo twice daily, with initial dose given 30 to 90 minutes prior to surgery. In Adolor’s previous phase III studies, the initial dose was to be administered at least 120 minutes prior to surgery.
The primary endpoint for the study is time to recovery of gastrointestinal function. This is a composite measure of the time to recovery of both upper and lower gastrointestinal function, as defined by time to tolerability of solid foods, and time to first bowel movement, whichever occurred last.
“We continue to target June 2006 to submit the final results from this study as part of our complete response to the FDA,” said Dr James Barrett, chief scientific officer at Adolor Corporation.