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Adolor Corporation Announces Issuance of U.S. Patent for ADL6906, an Analgesic Compound with a Novel Mechanism of Action
Wednesday, November 10, 2010
Exton, PA -- Adolor Corporation (NasdaqGM: ADLR) today announced that the U.S. Patent and Trademark Office has issued U.S. Patent No. 7,829,576 covering the use of ADL6906 (beloxepin), a small molecule, for the treatment of pain. The issued patent will expire on February 19, 2029.
The compound was previously studied by a pharmaceutical company in late-stage clinical trials in over 1,000 patients for the treatment of depression, where it demonstrated a good safety profile. Adolor is repositioning ADL6906 as a potential treatment for pain conditions and currently is conducting Phase 1 clinical evaluation of the compound.
"We are pleased to announce the issuance of this patent for ADL6906,” said Michael R. Dougherty, President and Chief Executive Officer. "ADL6906 represents an important addition to our clinical development portfolio, and we look forward to reporting on our progress in further studies."
The ongoing Phase 1 multiple ascending dose study is evaluating the safety, tolerability and pharmacokinetics (PK) of ADL6906 administered orally twice daily over 10 days in healthy volunteers.
Serotonin (5-HT) and norepinephrine (NE) in the brain and spinal cord are believed to help regulate the perception of pain. Reduced levels of endogenous NE and 5-HT activity at both spinal and supraspinal levels are believed to contribute substantially to chronic pain. It is suggested that the dual 5-HT/NE reuptake inhibitors (SNRIs) attenuate pain by increasing levels of NE and 5-HT post-synaptically, leading to activation of the descending inhibitory pain pathway. Combining drugs that act at different receptors and on different pain mechanisms is commonly used in clinical practice to treat various pain conditions. As a result, there is a significant interest in identifying novel analgesics interacting specifically with multiple pain targets.
ADL6906 is a dual NE reuptake inhibitor and 5-HT2 receptor antagonist giving ADL6906 a novel, unique and potentially differentiating pharmacological profile for treating pain. ADL6906 is active in several preclinical models of inflammatory pain, neuropathic pain, post-operative pain and acute pain after oral administration. Preclinical studies conducted at Adolor also suggest that the robust preclinical analgesic efficacy of ADL6906 is the result of a complementary effect between the dual mechanisms of action of NE reuptake inhibition and 5-HT2receptor antagonism.
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®, 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; two noveldelta opioid receptor agonists, one of which currently is in mid-stage clinical development in collaboration with Pfizer Inc. for neuropathic pain; 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; anticipated scientific progress on Adolor's research programs; development of potential pharmaceutical products, including ADL6906 and the timing and results of a Phase 2 study; interpretation of clinical results, including the results of the MAD study of ADL6906; 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.
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