Adolor Initiates Phase 2a Study of Delta Agonist ADL5859 in Neuropathic Pain

Adolor Corporation (Nasdaq: ADLR) announced today the initiation of a third Phase 2a study of ADL5859, a novel Delta opioid agonist in development for the treatment of pain. Study 33CL231 will explore the analgesic efficacy of ADL5859 in treating pain associated with diabetic peripheral neuropathy. Recently, Adolor and Pfizer Inc (NYSE: PFE) entered into a collaboration to develop and commercialize two Delta opioid agonist compounds, including ADL5859, for the treatment of a wide range of inflammatory, neuropathic and acute pain conditions. "We are pleased to be advancing the clinical development of ADL5859,” said Michael R. Dougherty, president and chief executive officer of Adolor Corporation. "This is our third Phase 2a ADL5859 Study and the first one announced since our collaboration with Pfizer earlier this month.” Study 33CL231 is a double-blind trial expected to enroll approximately 210 patients experiencing pain associated with diabetic peripheral neuropathy. Following a 7-day baseline period, patients will be randomized to receive a 4-week treatment of either placebo, ADL5859, or the active control, duloxetine. The primary measure of efficacy for the study will be the change in mean pain intensity score. With the initiation of 33CL231, ADL5859 is now being evaluated in Phase 2a studies involving acute pain following dental surgery, inflammatory pain associated with rheumatoid arthritis, and pain associated with diabetic peripheral neuropathy. About the Delta Receptor Program The Delta receptor is one of three opioid receptors. Through a proprietary research platform based on cloned, human opioid receptors, Adolor has identified a series of novel, orally active Delta agonists – compounds that selectively stimulate the Delta opioid receptor. Delta compounds may have a number of potential advantages, including an improved side effect profile, as compared to mu opioid receptor agonists. On the basis of preclinical evaluation in animal models of human conditions, one might expect a Delta agonist to show effect in inflammatory pain, among other pain conditions. In addition, Delta agonists are thought to modulate other biological processes that may manifest themselves in disease states or conditions such as cardioprotection, overactive bladder, and depression. There are currently no selective Delta agonists approved by the FDA. About the Delta Collaboration Adolor and Pfizer Inc (NYSE: PFE) are collaborating on the worldwide development and commercialization of two novel Delta opioid agonist compounds, ADL5859 and ADL5747, for the treatment of pain. About Adolor Corporation Adolor Corporation (Nasdaq:ADLR) is a biopharmaceutical company specializing in the discovery, development and commercialization of novel prescription pain management products. Adolor has two lead product candidates in development: Entereg® (alvimopan) for the management of the gastrointestinal side effects associated with opioid use; and, novel Delta opioid receptor agonists for a variety of pain indications. Adolor and GlaxoSmithKline are collaborating in the worldwide development and commercialization of Entereg in multiple indications. Adolor and Pfizer are collaborating in the worldwide development and commercialization of two Delta agonists for 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. For more information, visit www.adolor.com. Adolor Forward-Looking Statement 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 our Delta product candidates ADL5859 and ADL5747 will show adverse safety findings that make them unsuitable for further development; the risk that our Delta product candidates do not show utility in treating pain or any other clinical indications; the risk that we do not initiate further clinical studies for our product candidate ADL5859 or initiate clinical studies for our product candidate ADL5747; the risk that filing targets for regulatory filings are not met; 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 Pfizer in connection with the development and commercialization of Adolor’s Delta product candidates; the risks associated with Adolor’s ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection of its Delta product candidates; market acceptance of Adolor's products, if regulatory approval is achieved; reliance on third party manufacturers; product liability claims; 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.