Adolor Corporation Initiates Clinical Testing in Opioid Bowel Dysfunction Program
November 12 2009 - 9:00AM
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.
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