Adolor Corporation (NasdaqGM: ADLR) today announced that
ENTEREG® (alvimopan) will be the subject of presentations at the
2011 Annual Scientific Meeting of the American Society of Colon
& Rectal Surgeons (ASCRS) on Monday and Tuesday, May 16-17,
2011. The presentations are scheduled from 9:00 a.m. to 4:00 p.m.
EDT on Monday, May 16 and from 9:00 a.m. to 1:30 p.m. on May 17,
2011 in Exhibit Hall A, West Building at the Vancouver Convention
Centre, Vancouver, Canada.
A poster1 reporting the evaluation of ENTEREG use in clinical
practice using a large in-patient database will be presented. The
study evaluated clinical outcomes, length of stay, and estimated
total hospital cost in bowel resection patients with and without
exposure to ENTEREG. The retrospective cohort study was conducted
using 2009 exact matched (surgical procedure, surgeon specialty)
and propensity score matched (baseline patient, surgeon, and
hospital characteristics) data from a national inpatient
administrative database. The abstract is available on the ASCRS
2011 Annual Meeting website.
“This study of the use of ENTEREG in the clinical practice
setting adds to the growing body of available literature regarding
the use of the product,” said Lee M. Techner, D.P.M., Vice
President, Medical Affairs, Pharmacovigilance & Drug Safety at
Adolor and one of the study’s authors.
In addition to this poster, there will be three additional
ENTEREG-related poster presentations at the ASCRS 2011 Annual
Meeting. All of these abstracts are currently available online for
viewing through the ASCRS 2011 Annual Meeting website.
About ENTEREG
ENTEREG (alvimopan) is a peripherally acting mu-opioid receptor
antagonist that was approved by the U.S. Food and Drug
Administration in mid-2008. ENTEREG is the first and only FDA
approved therapy indicated to accelerate the time to upper and
lower gastrointestinal (GI) recovery following partial large or
small bowel resection surgery with primary anastomosis.
ENTEREG was evaluated in five Phase 3 clinical studies, four in
North America, that enrolled more than 1,850 bowel resection
patients (including those in the placebo groups). The recommended
adult dose of ENTEREG is a single 12 mg capsule administered orally
30 minutes to five hours prior to surgery followed by a 12 mg
capsule twice daily beginning the day after surgery for a maximum
of seven days or until discharge, not to exceed 15 doses. ENTEREG
is for use in hospitalized patients only (see Important Safety
Information below).
ENTEREG is available only to hospitals that perform bowel
resections and are enrolled in the ENTEREG Access Support &
Education (E.A.S.E.™) program.
Important Safety Information for
ENTEREG
WARNING: FOR SHORT-TERM HOSPITAL USE
ONLY
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
& Education (E.A.S.E.) program may use ENTEREG.
Contraindications
ENTEREG is contraindicated in patients who
have taken therapeutic doses of opioids for more than 7 consecutive
days immediately prior to taking ENTEREG.
Warnings and Precautions
There were more reports of myocardial
infarctions in patients treated with alvimopan 0.5 mg twice daily
compared with placebo treated patients in a 12-month study of
patients treated with opioids for chronic pain. In this study, the
majority of myocardial infarctions occurred between 1 and 4 months
after initiation of treatment. This imbalance has not been observed
in other studies of alvimopan, including studies of patients
undergoing bowel resection surgery who received alvimopan 12 mg
twice daily for up to 7 days. A causal relationship with alvimopan
has not been established.
ENTEREG should be administered with
caution to patients receiving more than 3 doses of an opioid within
the week prior to surgery. These patients may be more sensitive to
ENTEREG and may experience GI side effects (e.g., abdominal pain,
nausea and vomiting, diarrhea).
ENTEREG is not recommended for use in
patients with severe hepatic impairment, end-stage renal disease,
or in patients undergoing surgery for correction of complete bowel
obstructions.
Most common adverse reactions in patients
treated with ENTEREG (incidence > 3% with ENTEREG and at least
1% greater than placebo) undergoing bowel resection were anemia,
dyspepsia, hypokalemia, back pain, and urinary retention.
For more information about ENTEREG,
including full Prescribing Information and the E.A.S.E. Program,
contact Adolor Corporation at 1-866-4ADOLOR (1-866-423-6567) or
visit www.entereg.com.
About Adolor
Adolor Corporation is a biopharmaceutical company specializing
in the discovery, development and commercialization of novel
prescription pain and pain management products.
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;
anticipated scientific progress on Adolor’s research programs;
development of potential pharmaceutical products; 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.
1 “Evaluation of Alvimopan in Clinical Practice: A National
Matched-cohort Study of 30-Day Postoperative In-hospital Morbidity
and Mortality in Patients Undergoing Bowel Resection” (P267;C.
Delaney, C. Christopher Craver, M. Maggard Gibbons, A. Rachfal, C.
VandePol, S. Cook, S. Poston, M. Calloway, L. Techner).
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