Adolor Corporation Expands Phase 2 Opioid Induced Constipation Program
January 10 2011 - 8:00AM
Business Wire
Adolor Corporation (NasdaqGM: ADLR) today announced that it is
initiating a second Phase 2 study of ADL5945 in chronic non-cancer
pain patients suffering from opioid-induced constipation (OIC).
The Company’s first Phase 2 study of this compound initiated in
October 2010 and is evaluating two doses of ADL5945 (0.10 mg and
0.25 mg) each administered twice daily in patients with OIC. This
second Phase 2 study of ADL5945, which will assess a single dose of
0.25 mg once daily versus placebo in the same study design, is
intended to complete the dosing assessment of ADL5945 in
anticipation of a Phase 3 program.
“The addition of this once-daily dosing study will expand our
understanding of the efficacy, safety and tolerability of ADL5945,
and the successful completion of the Phase 2 program should enable
us to select a dose for pivotal confirmatory studies,” said Michael
R. Dougherty, President and Chief Executive Officer. “We look
forward to reporting results from these studies in the summer of
2011 and moving the program forward into pivotal studies in early
2012.”
About Adolor
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®(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 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; 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 in 2011
and beyond; anticipated scientific progress on Adolor’s research
programs; development of potential pharmaceutical products,
including ADL5945, the timing of the Phase 2 studies of this
compound or of any subsequent Phase 3 studies of this compound, and
whether a Phase 3 program for ADL5945 will be commenced at any time
in the future; interpretation of clinical results, including
results from the Phase 2 studies of ADL5945 and whether the results
of such studies will expand the Company’s understanding of the
efficacy, safety and tolerability of ADL5945 and enable the Company
to select the dose for Phase 3 studies; 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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