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Treatment 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

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