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Adolor Corporation Initiates Clinical Testing in Opioid Bowel Dysfunction Program.


EXTON, Pa. -- Adolor Corporation (NasdaqGM:ADLR) today announced the initiation of clinical testing of ADL7445, its proprietary, oral mu opioid receptor The μ opioid receptors (MOR) are a class of opioid receptors with high affinity for enkephalins and beta-endorphin but low affinity for dynorphins. The opiate alkaloids morphine and codeine are known to bind to this receptor.  antagonist for the treatment of Opioid Bowel Dysfunction (OBD). The Phase 1, single ascending dose trial in healthy volunteers will assess safety and tolerability of the compound and will be followed by a multiple ascending dose study in early 2010.

Early next year, the Company also expects to initiate a clinical study of a second compound for OBD, ADL5945, in a parallel, early-stage clinical development program. ADL5945 was in-licensed from Eli Lilly Eli Lilly can refer to:
  • Eli Lilly and Company, a global pharmaceutical company
  • Colonel Eli Lilly (1839-1898), founder of Eli Lilly and Company
  • Eli Lilly (industrialist) (1885-1977), former president of Eli Lilly and Company
 in September 2009 and has a different chemical structure and pharmacokinetic profile than ADL7445.

"We are very pleased to commence clinical testing in our OBD Program with the first of two promising compounds," said Eliseo Salinas, M.D., Senior Vice President and Chief Medical Officer. "Our clinical development team possesses a wealth of experience in this therapeutic area, and we are committed to developing products that will address this large, unmet need."

About Opioid Bowel Dysfunction

Opioids are highly effective in the treatment of pain and are widely used to treat moderate-to-severe persistent pain such as pain associated with, or as a result of, back pain, arthritis and other chronic pain conditions. However, the use of opioids is associated with gastrointestinal (GI) side effects Side effects

Effects of a proposed project on other parts of the firm.
 such as constipation, abdominal pain and discomfort, bloating, gastro-oesophageal reflux and loss of appetite loss of appetite Medtalk Anorexia, see there . These GI effects, which do not resolve over time, occur when opioids bind to mu-opioid receptors in the gut, reducing gastrointestinal motility motility /mo·til·i·ty/ (mo-til´ite) the ability to move spontaneously.mo´tile
Motility
Motility is spontaneous movement.
 and secretions. The consequences are not only distressing, but they may, in some patients, be dose-limiting for the pain therapy, which can then interfere with adequate pain control.

There currently are no approved oral drugs specifically for the treatment of GI adverse events associated with opioid use for persistent pain. Taking stool softeners and/or bowel stimulants, increasing daily fluid and fiber intake and increasing exercise are methods often used to manage this condition. Laxatives may provide limited relief for some patients, but also can be associated with side effects such as abdominal cramping, bloating and unpredictability of effect, and are not recommended for long-term use.

About Adolor Corporation

Adolor Corporation is a biopharmaceutical company specializing in the discovery, development and commercialization of novel prescription pain management products.

Adolor's first approved product in the United States is ENTEREG[R] (alvimopan), which is indicated to accelerate the time to upper and lower gastrointestinal recovery following partial large or small bowel small bowel
n.
See small intestine.
 resection surgery with primary anastomosis anastomosis /anas·to·mo·sis/ (ah-nas?tah-mo´sis) pl. anastomo´ses   [Gr.]
1. communication between vessels by collateral channels.

2.
. ENTEREG is available for short-term use in hospitals registered under the E.A.S.E.[TM] Program. For more information on ENTEREG, including its full prescribing information, visit www.ENTEREG.com. In collaboration with GlaxoSmithKline (GSK GSK GlaxoSmithKline plc (pharmaceutical company)
GSK Glycogen Synthase Kinase
GSK Gruppentraining Sozialer Kompetenzen (Germany)
GSK Greenland Shark (FAO fish species code) 
), the Company launched ENTEREG in mid-2008.

The Company's research and development pipeline includes: two novel delta opioid receptor δ-Opioid receptors are a class of opioid receptor which have enkephalins as their endogenous ligands. Function
Activation of the receptors produces analgesia. Some research suggests that they may also be related to seizures.
 agonists, currently in mid-stage clinical development in collaboration with Pfizer Inc. for chronic pain; two opioid receptor antagonists, ADL7445 and ADL5945, entering clinical development for opioid bowel dysfunction (OBD); and several opioid and non-opioid discovery programs.

For more information, visit www.adolor.com.

Forward-Looking Statements

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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  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 the Company's expectations with respect to the clinical plans, timelines and results in its OBD programs; interpretation of clinical results; 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.
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Publication:Business Wire
Geographic Code:1U2PA
Date:Nov 12, 2009
Words:853
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