EXTON, Pa.--(BUSINESS WIRE)-- Adolor Corporation (NasdaqGM: ADLR) today announced that it is initiating a second Phase 2 study of ADL5945 in chronic non-cancer pain patients suffering from opioid-induced constipation (OIC).
The Company’s first Phase 2 study of this compound initiated in October 2010 and is evaluating two doses of ADL5945 (0.10 mg and 0.25 mg) each administered twice daily in patients with OIC. This second Phase 2 study of ADL5945, which will assess a single dose of 0.25 mg once daily versus placebo in the same study design, is intended to complete the dosing assessment of ADL5945 in anticipation of a Phase 3 program.
“The addition of this once-daily dosing study will expand our understanding of the efficacy, safety and tolerability of ADL5945, and the successful completion of the Phase 2 program should enable us to select a dose for pivotal confirmatory studies,” said Michael R. Dougherty, President and Chief Executive Officer. “We look forward to reporting results from these studies in the summer of 2011 and moving the program forward into pivotal studies in early 2012.”
Adolor Corporation is a biopharmaceutical company specializing in the discovery, development and commercialization of novel prescription gastrointestinal and pain management products.
Adolor’s first approved product in the United States is ENTEREG®(alvimopan), which is indicated to accelerate the time to upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis. ENTEREG is available for short-term use in hospitals registered under the E.A.S.E.® Program. For more information on ENTEREG, including its full prescribing information, visit www.ENTEREG.com. In collaboration with GSK, the Company launched ENTEREG in mid-2008.
The Company's research and development pipeline includes: ADL5945 and ADL7445, novel mu opiate receptor antagonists undergoing clinical development for chronic OIC; and several earlier-stage compounds under development for the management of pain and CNS disorders.
For more information, visit www.adolor.com.
This press release, and oral statements made with respect to information contained in this release, may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements provide Adolor’s current expectations or forecasts of future events. These may include statements regarding market prospects for ENTEREG in 2011 and beyond; anticipated scientific progress on Adolor’s research programs; development of potential pharmaceutical products, including ADL5945, the timing of the Phase 2 studies of this compound or of any subsequent Phase 3 studies of this compound, and whether a Phase 3 program for ADL5945 will be commenced at any time in the future; interpretation of clinical results, including results from the Phase 2 studies of ADL5945 and whether the results of such studies will expand the Company’s understanding of the efficacy, safety and tolerability of ADL5945 and enable the Company to select the dose for Phase 3 studies; prospects for regulatory approvals; and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning or that otherwise express contingencies, goals, targets or future development. These statements are based upon management’s current expectations and are subject to risks and uncertainties, known and unknown, that could cause actual results and developments to differ materially from those expressed or implied in such statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries, as well as more specific risks and uncertainties facing Adolor such as those set forth in its reports on Forms 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 at www.sec.gov and from Adolor at www.adolor.com. Given the uncertainties affecting pharmaceutical companies such as Adolor, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Adolor undertakes no 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, except as may be required by law.
This press release is available on the website http://www.adolor.com.
Stephen W. Webster, 484-595-1500
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