Adolor Corp. (MM) (NASDAQ:ADLR)
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5 Years : From Mar 2014 to Mar 2019
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
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-HT2 receptor 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 novel delta 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
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.
This press release is available on the website http://www.adolor.com.