Adolor Corporation Completes Enrollment In Phase 3 Study 314 Of Entereg(R) (Alvimopan) In Postoperative Ileus

EXTON, Pa., Nov. 28 /PRNewswire-FirstCall/ -- Adolor Corporation announced today that it had completed enrollment of study 14CL314. This Phase 3 clinical trial, comprising approximately 660 patients, is evaluating Entereg(R) (alvimopan) for the management of postoperative ileus (POI) by acceleration of the time to recovery of gastrointestinal (GI) function following bowel resection surgery.

"We are pleased to have accomplished this milestone on schedule, putting us on track to achieve our goal of reporting top-line data by March 2006," said James Barrett, Ph.D., senior vice president, chief scientific officer and president, research of Adolor Corporation. "We continue to target June 2006 to submit the final results from this study as part of our complete response to the FDA."

Study 14CL314 is a double-blind, placebo controlled pivotal clinical trial. Under the protocol, patients were randomized to receive either 12 mg Entereg(R) (alvimopan) or placebo twice daily, with initial dose given 30 to 90 minutes prior to surgery. In Adolor's previous Phase 3 studies, the initial dose was to be administered at least 120 minutes prior to surgery. The primary endpoint for Study 314 is time to recovery of GI function. This is 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.

Adolor submitted a new drug application (NDA) to the Food and Drug Administration (FDA) for Entereg(R) in June 2004 and received an approvable letter in July 2005.

About Adolor Corporation

Adolor Corporation is a biopharmaceutical company specializing in the discovery, development and commercialization of novel prescription pain management products. Entereg(R) (alvimopan) is Adolor's lead product candidate under development for the management of the gastrointestinal side effects associated with opioid use. Adolor and GlaxoSmithKline (GSK) are collaborating in the worldwide development and commercialization of Entereg(R) in multiple indications. Adolor is developing a sterile lidocaine patch which is in Phase 2 clinical development for post-surgical 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 Corporation is seeking to make a positive difference for patients, caregivers and the medical community. For more information, visit www.adolor.com.

This release, and oral statements made with respect to information contained in this release, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward- looking statements include those which express plan, anticipation, intent, contingency, goals, targets or future development and/or otherwise are not statements of historical fact. These statements are based upon management's current expectations and are subject to risks and uncertainties, known and unknown, which could cause actual results and developments to differ materially from those expressed or implied in such statements. Such known risks and uncertainties relate to, among other factors: the risk that Adolor may not meet its targets for top-line data for Study 314 or for submission of a complete response to FDA for the pending new drug application (NDA) for Entereg(R) in postoperative ileus (POI); the risk that Adolor may not obtain FDA approval for the NDA for Entereg(R) in POI, whether due to the risk that: Adolor is not be able to provide additional data satisfactory to the FDA to obtain approval for the NDA; the results of Study 314 are not positive; Adolor is not able to justify that the median reduction in time to gastrointestinal (GI) recovery seen in bowel resection patients treated with Entereg(R) is clinically meaningful; the adequacy of the results of the Studies 14CL302, 14CL306, 14CL308 and 14CL313 to support FDA approval of Entereg(R), the results from other clinical trials of Entereg(R), including the GlaxoSmithKline Phase 3 Study 001, the adequacy of the development program, the conduct of the clinical trials, changing regulatory requirements, different methods of evaluating and interpreting data, reliance on third party manufacturers, adverse safety findings or otherwise; the risk that the FDA may not agree with Adolor's analyses of Studies 14CL302, 14CL306, 14CL308 and 14CL313 and may evaluate the results of these studies by different methods or conclude that the results from the studies are not statistically significant, clinically meaningful or do not support safety or that there were human errors in the conduct of the studies or otherwise; the risk that further studies of Entereg(R) in OBD are not positive; the risk that the results of Study 001 do not support a submission of a marketing approval application for alvimopan in Europe; the costs, delays and uncertainties inherent in scientific research, drug development, clinical trials and the regulatory approval process; Adolor's history of operating losses since inception and its need for additional funds to operate its business; Adolor's reliance on its collaborators, including GlaxoSmithKline in connection with the development and commercialization of Entereg(R); market acceptance of Adolor's products, if regulatory approval is achieved; competition; and securities litigation.

Further information about these and other relevant risks and uncertainties may be found in Adolor's Reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Adolor urges you to carefully review and consider the disclosures found in its filings which are available in the SEC EDGAR database at http://www.sec.gov and from Adolor at http://www.adolor.com. Given the uncertainties affecting pharmaceutical companies in the development stage, you are cautioned not to place undue reliance on any such forward-looking statements, any of which may turn out to be wrong due to inaccurate assumptions, unknown risks, uncertainties or other factors. Adolor undertakes no obligation to (and expressly disclaims any such obligation to) publicly update or revise the statements made herein or the risk factors that may relate thereto whether as a result of new information, future events, or otherwise.

CONTACT: Lizanne Wentz, Corporate Communications, Adolor Corporation,+1-484-595-1500; Sam Brown Inc. (media), Mike Beyer, +1-773-463-4211; SternInvestor Relations (investors), Lilian Stern, +1-212-362-1200, both forAdolor Corporation

Web site: http://www.adolor.com/