EnteregTreatment for Postoperative Ileus
Update: Entereg Now FDA Approved - May 20, 2008
Adolor Announces FDA Update
EXTON, Pa., January 10, 2005 -- Adolor Corporation (NASDAQ:ADLR) announced today that the U.S. Food and Drug Administration (FDA), as part of its review of Adolor's New Drug Application (NDA) for Entereg (alvimopan), has requested that the company provide information from the GlaxoSmithKline (GSK) European Phase 3 clinical study (SB-767905/001) of alvimopan in postoperative ileus (POI). Study 001 was conducted by GSK in Europe, Australia and New Zealand to support a Marketing Authorization Application (MAA) in the European Union. Top-line results from Study 001 were announced by Adolor on December 23, 2004. Adolor and GSK are collaborating on the worldwide development and commercialisation of alvimopan.
"We will work closely with our partner GSK to provide this information to the FDA," said Bruce Peacock, president and chief executive officer of Adolor Corporation. "Our goal is to deliver the information in a time frame that would allow for an extension of three months to the Prescription Drug User Fee Act (PDUFA) target action date of April 25, 2005."
"A number of positive findings and the safety profile of Study 001 validate observations in previous studies," commented Dr. Yvonne Greenstreet, Senior Vice President, Medicine Development Centre at GlaxoSmithKline. "We believe that the information from the Study will be valuable to the FDA in its consideration of the Entereg NDA."
About Adolor Corporation
Adolor Corporation (NASDAQ:ADLR) is a biopharmaceutical company specializing in the discovery, development and commercialization of novel prescription pain management products. Entereg (alvimopan) is Adolor's lead product candidate. Adolor is developing a sterile lidocaine patch, which is in Phase 2 clinical development for post-incisional pain. Adolor also has a number of discovery research programs focused on the identification of novel compounds for the treatment of pain. By applying its knowledge and expertise in pain management, along with ingenuity, Adolor is seeking to make a positive difference for patients, caregivers and the medical community.
Posted: January 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 CommitteeMeeting for Entereg (alvimopan) for the Management of PostoperativeIleus in Bowel Resection - January 24, 2008
- Adolor Announces Availability of Briefing Documents For January23rd FDA Advisory Committee Meeting on Entereg (alvimopan) - January 18, 2008
- Adolor and GlaxoSmithKline Announce FDA Advisory Committee toReview Entereg (alvimopan) for the Management of PostoperativeIleus (POI) - November 28, 2007
- FDA Accepts for Review Complete Response to Approvable Letter forEntereg (alvimopan) for POI - August 28, 2007
- GSK and Adolor Update Alvimopan (Entereg/Entrareg) DevelopmentProgram - 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 Receives FDA Approvable Letter for Entereg - July 22, 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