Adolor Corporation Initiates Clinical Testing in Opioid Bowel Dysfunction Program

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Thu Nov 12, 2009 9:00am EST

EXTON, Pa.--(Business Wire)--
Adolor Corporation (NasdaqGM:ADLR) today announced the initiation of clinical
testing of ADL7445, its proprietary, oral mu opioid 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 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 such as
constipation, abdominal pain and discomfort, bloating, gastro-oesophageal reflux
and loss of appetite. These GI effects, which do not resolve over time, occur
when opioids bind to mu-opioid receptors in the gut, reducing gastrointestinal
motility 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 (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
GlaxoSmithKline (GSK), the Company launched ENTEREG in mid-2008. 

The Company`s research and development pipeline includes: two novel delta opioid
receptor 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 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.

Adolor Corporation
Lizanne Wentz
Corporate Communications
484-595-1500 

Copyright Business Wire 2009

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