EnteregTreatment for Postoperative Ileus
Update: Entereg Now FDA Approved - May 20, 2008
Adolor Receives FDA Approvable Letter for Entereg
PHILADELPHIA and EXTON, Pa., July 22, 2005 -- Adolor Corporation and GlaxoSmithKline announced today that Adolor has received an approvable letter from the U.S. Food and Drug Administration (FDA) for Entereg (alvimopan) capsules, an investigational drug under review for the management of postoperative ileus (POI) by acceleration of the time to recovery of gastrointestinal (GI) function following bowel resection surgery. The new drug application (NDA) for Entereg was submitted in June 2004.
Before the application may be approved, it will be necessary to provide additional proof of efficacy to the FDA to support the use of Entereg following bowel resection surgery. The FDA indicated that this may be achieved by demonstrating statistically significant results in at least one additional clinical study, and that this could potentially be addressed with positive results from Adolor's ongoing Study 14CL314. The FDA also indicated that the Company must provide justification that the median reduction in time to gastrointestinal recovery seen in bowel resection patients treated with Entereg is clinically meaningful.
"We intend to request a meeting with the FDA as quickly as possible to discuss the approvable letter and determine the appropriate next steps for the NDA," said Bruce Peacock, president and chief executive officer of Adolor Corporation.
About Study 14CL314
Adolor is currently conducting Study 314 in POI. Study 314 has been designed to enroll 660 bowel resection patients, randomized into two arms to receive either placebo or 12 mg of Entereg twice daily. The protocol for Study 314 provides that the initial dose of Entereg should be administered 30 to 90 minutes prior to surgery, as compared to Adolor's previous Phase 3 studies where the first dose was required to be administered (at least) 120 minutes prior to surgery. The primary endpoint of Study 314 is time to recovery of GI function ("GI2"), a composite measure of the time to recovery of both upper and lower GI function, as defined by time to tolerability of solid foods, and time to first bowel movement, whichever occurred last.
About Entereg (alvimopan)
Entereg (alvimopan) is an investigational peripherally-acting mu-opioid receptor (PAM-OR) antagonist designed to inhibit the negative effects of opioids, like morphine, on the gastrointestinal system without interfering with the analgesic effects in the central nervous system.
Adolor Corporation and GlaxoSmithKline are collaborating on the worldwide development and commercialization of Entereg for POI and opioid-induced bowel dysfunction (OBD) associated with extended use of opioids to treat chronic pain.
Posted: July 2005
- Adolor and GlaxoSmithKline Announce FDA Approval of Entereg (alvimopan) for the Management of Postoperative Ileus (POI) - May 21, 2008
- Adolor Provides Regulatory Update on Entereg (alvimopan) - May 9, 2008
- FDA Extends Review of NDA for Entereg (alvimopan) - February 11, 2008
- Adolor and GlaxoSmithKline Report Favorable FDA Advisory Committee Meeting for Entereg (alvimopan) for the Management of Postoperative Ileus in Bowel Resection - January 24, 2008
- Adolor Announces Availability of Briefing Documents For January 23rd FDA Advisory Committee Meeting on Entereg (alvimopan) - January 18, 2008
- Adolor and GlaxoSmithKline Announce FDA Advisory Committee to Review Entereg (alvimopan) for the Management of Postoperative Ileus (POI) - November 28, 2007
- FDA Accepts for Review Complete Response to Approvable Letter for Entereg (alvimopan) for POI - August 28, 2007
- GSK and Adolor Update Alvimopan (Entereg/Entrareg) Development Program - June 11, 2007
- FDA Issues Approvable Letter for Entereg (alvimopan) for POI - November 6, 2006
- Adolor’s Complete Response to Approvable Letter Accepted for Review by FDA - May 31, 2006
- Adolor Announces FDA Update - January 10, 2005
- FDA Accepts Entereg for Review - September 8, 2004
- Adolor Completes Submission of NDA for Entereg - June 28, 2004
- Adolor Submits Second Portion of NDA for Entereg - June 1, 2004
- Adolor Submits First Portion of NDA for Entereg - May 7, 2004