Adolor Corporation (NasdaqGM: ADLR) today announced that the
results of a Medication Use Evaluation (MUE) conducted by clinical
pharmacists and surgeons at the Moses Cone Health System in North
Carolina have been published in the November print edition of The
Annals of Pharmacotherapy. The objective of the study was to assess
the efficacy, safety and economic benefit of ENTEREG® (alvimopan)
in patients undergoing large or small bowel resection surgery with
primary anastomosis in a community hospital setting.
This MUE was conducted from October 1, 2008 through September
30, 2009 and included a 6-month, open-label, multi-hospital
prospective study combined with a 6-month retrospective chart
review. Data for 108 patients who received ENTEREG and 91
historical control patients were collected from open bowel
resections and laparoscopic bowel resection procedures with primary
anastomosis performed by 23 surgeons at three hospitals.
“The results of this MUE confirmed that using ENTEREG in this
hospital system contributed to earlier discharge after surgery and,
importantly, reduced mean hospital costs,” said Randall K. Absher,
PharmD, BCPS, Senior Clinical Coordinator, Wesley Long Community
Hospital Pharmacy, Moses Cone Health System, Greensboro, NC, and
the lead author of the study.
ENTEREG is the first and only FDA-approved therapy indicated to
accelerate the time to upper and lower gastrointestinal recovery
following partial large or small bowel resection surgery with
primary anastomosis.
“We are delighted to see the publication of this MUE, as it
reinforces our belief in the medical and economic benefits of
ENTEREG and confirms results observed in our clinical trials,” said
Lee M. Techner, D.P.M., Vice President, Medical Affairs,
Pharmacovigilance & Drug Safety at Adolor. “We look forward to
seeing the results of additional independently-conducted studies on
the potential health economic benefits of ENTEREG in real world
clinical practice settings.”
About ENTEREG
ENTEREG 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 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 hospital use 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. This program is designed to maintain
the benefits associated with short-term use in the bowel resection
population and prevent long-term, outpatient use.
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
E.A.S.E. Program may use ENTEREG.
Important Safety Information
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.
Patients recently exposed to opioids are expected to be more
sensitive to the effects of mu-opioid receptor antagonists. Since
ENTEREG acts peripherally, clinical signs and symptoms of increased
sensitivity would likely be limited to the gastrointestinal tract
(e.g., abdominal pain, nausea and vomiting, diarrhea). Patients
receiving more than 3 doses of an opioid within the week prior to
surgery were not studied in the postoperative ileus clinical
trials; therefore, ENTEREG 12 mg capsules should be administered
with caution to these patients.
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.
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 gastrointestinal 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 opioid-induced constipation; 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 CNS disorders.
For more information, visit www.adolor.com.
About the Authors of the Study Report
The authors of the article entitled “Alvimopan Use in
Laparoscopic and Open Bowel Resections: Clinical Results in a Large
Community Hospital System” are Dr. Absher, Todd M. Gerkin, M.D.,
FACS, and Linda W. Banares, PharmD. Drs. Absher and Gerkin are paid
speakers for ENTEREG on behalf of Adolor. In addition, Dr. Absher
has served on an advisory board for Adolor. Funding for medical
editorial assistance for this manuscript was provided by
Adolor.
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.
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