Adolor Corporation Completes Enrollment in Phase 2 OIC Program
June 06 2011 - 8:00AM
Business Wire
Adolor Corporation (NasdaqGM: ADLR) today announced that it has
completed enrollment in its Phase 2 clinical evaluation of ADL5945
in chronic, non-cancer pain patients with opioid-induced
constipation (OIC).
Adolor is conducting two Phase 2 studies of ADL5945 in OIC
patients in parallel. The first study is evaluating two doses of
ADL5945 – 0.10 mg and 0.25 mg – given twice daily versus placebo
over a 4-week, double-blind treatment period. The second study, of
similar design, is evaluating 0.25 mg of ADL5945 given once daily
versus placebo. The trials have enrolled 40 or more patients in
each arm, for a combined total of over 200 patients.
“Enrollment has progressed quite well in these studies,” said
Michael R. Dougherty, President and Chief Executive Officer. “We
look forward to reporting results in the third quarter of this
year, and to advancing ADL5945 into pivotal testing in the first
quarter of 2012. OIC is a frequent and serious consequence of
long-term opioid-based pain management and an effective treatment
for this condition remains an unmet medical need.”
About ADL5945
ADL5945 is a potent, peripherally-acting mu opioid receptor
antagonist intended to block the adverse effects of opioid
analgesics on the GI tract without compromising centrally-mediated
analgesia. Peripheral mu opioid receptors in the GI tract regulate
functions such as motility, secretion and absorption. Stimulation
of these GI mu opioid receptors by morphine, or other opioid
analgesics, disrupts normal gut motility. Ultimately, this results
in constipation, as well as other associated burdensome GI
symptoms.
During 2010, Adolor completed single dose and multiple-ascending
dose studies of ADL5945 that enrolled both healthy volunteers and
chronic non-cancer pain patients on long-term opioid therapy with
OIC. At target therapeutic doses, ADL5945 was well tolerated and,
in patients with OIC, produced greater increases (over baseline) in
weekly average number of spontaneous bowel movements as compared
with placebo.
About OIC
According to IMS Health, over 250 million opioid prescriptions
are written annually in the United States. For those patients
treated with prescription opioids for long term pain management, it
is estimated that approximately 50 percent will develop
constipation. Currently, there are no FDA-approved therapies to
treat opioid induced constipation in patients with chronic
non-cancer pain.
About Adolor
Adolor Corporation is a biopharmaceutical company specializing
in the discovery, development and commercialization of novel
prescription pain and 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 only for short-term (15 doses) use in hospitalized
patients. Only hospitals that have registered in and met all of the
requirements for the ENTEREG Access Support and Education
(E.A.S.E.) program may use ENTEREG. For more information on
ENTEREG, including its full prescribing information, the Boxed
Warning regarding short-term hospital use and the E.A.S.E.®
Program, visit www.ENTEREG.com. The Company co-promotes ENTEREG in
collaboration with GSK.
The Company's research and development pipeline includes:
ADL5945 and ADL7445, novel mu opioid receptor antagonists
undergoing clinical development for chronic OIC; and several
earlier-stage compounds under development for the management of
pain and CNS disorders.
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; the
development of potential pharmaceutical products, including
ADL5945; the timetables for the release of clinical results for the
Phase 2 studies of ADL5945 and the initiation of pivotal testing;
prospects for regulatory approvals; anticipated scientific progress
on Adolor’s research programs; 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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