Adolor Corporation (NASDAQ: ADLR) and GlaxoSmithKline (NYSE: GSK)
today announced that an economic analysis of Phase 3 clinical trial
data reported that the use of ENTEREG after bowel resection surgery
decreased the amount of time patients spent in the hospital by one
day, resulting in lower estimated hospital costs compared with
placebo. The results, published in the American Journal of
Health-System Pharmacy, were based on a post-hoc pharmacoeconomic
analysis of pooled data consisting of 1,409 patients who
participated in four randomized, double-blind, placebo-controlled,
Phase 3 efficacy studies of ENTEREG conducted in North America.
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, or reconnection of the intestine.
"The results from this analysis are positive for both bowel
resection patients and healthcare providers," said Anthony J.
Senagore, M.D., Vice President, Research and Education, Spectrum
Health, Grand Rapids, MI, and one of the study authors. "The
analysis of these Phase 3 North American studies concluded that
using ENTEREG contributed to earlier discharge after surgery and,
importantly, reduced overall estimated hospital costs."
Analysis design and results
Patients evaluated in the four Phase 3 trials received
standardized accelerated care treatment -- removal of nasogastric
tube before first postoperative dose, early ambulation, and early
feeding. Both placebo and ENTEREG were given orally once before
surgery and then twice daily beginning the day after surgery until
hospital discharge or for a maximum of 15 doses. Patients were
eligible to participate if they were 18 years of age or older, were
undergoing laparotomy for partial small or large bowel resection
with primary anastomosis, and were scheduled for postoperative pain
management with IV opioid-based analgesia.
This post-hoc pooled economic analysis showed that patients in
the group receiving ENTEREG experienced a mean hospital length of
stay (defined as the day of surgery to day that the discharge order
was written) of one day less than the placebo control group. In the
four North American Phase 3 trials, mean time-to-discharge-order
written (which represented LOS) for patients receiving ENTEREG was
between 13-21 hours shorter compared to those in the control group.
In those trials, the time in hours from the end of surgery to when
the discharge order was written represented the LOS. Mean estimated
hospital costs were less for patients taking ENTEREG compared to
the control group.
"We are very pleased to see these results published, as they
reinforce our belief in the value proposition of ENTEREG," said
Eliseo Salinas, MD, MSC, Senior Vice President, Research and
Development and Chief Medical Officer at Adolor. "This encouraging
pharmacoeconomic analysis was conducted in a setting where steps
were being taken to help bowel resection patients recover
gastrointestinal function faster, and those using ENTEREG clearly
saw benefit compared to placebo. We look forward to seeing the
results of independently-conducted analyses on the potential health
economic benefits of ENTEREG in real world clinical settings."
Such an independent analysis was presented recently at the 2009
Annual Meeting of the Northwest Society of Colon and Rectal
Surgeons in Sun River, Oregon, by Timothy Beard, MD, FACS.* Dr.
Beard, Director of Research, Bend Memorial Clinic in Bend, Oregon,
discussed his findings in his presentation, Incorporation of
Alvimopan as Part of Perioperative Management of Patients
Undergoing Colectomy: A Single Surgeon's Experience.
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.
The benefits of ENTEREG were demonstrated 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.(TM)) 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.
Adolor is collaborating with GlaxoSmithKline (GSK) for the
continued development and commercialization of ENTEREG.
About Adolor Corporation
Adolor Corporation (NASDAQ: ADLR) is a biopharmaceutical company
specializing in the discovery, development and commercialization of
novel prescription pain management products. For more information,
visit www.adolor.com.
About GlaxoSmithKline
GlaxoSmithKline is one of the world's leading research-based
pharmaceutical and healthcare companies and is committed to
improving the quality of human life by enabling people to do more,
feel better and live longer. For more information, visit
GlaxoSmithKline on the World Wide Web at www.gsk.com.
About the Authors of the Studies
The authors of the article entitled "Economic Analysis of
alvimopan in North American Phase III Efficacy Trials" are either
employees of Adolor Corporation or GlaxoSmithKline or paid
consultants to one or both companies.
* Dr. Timothy Beard is a member of the Speakers' Bureau for
Adolor and GlaxoSmithKline.
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 anticipated scientific progress on its
research programs; development of potential pharmaceutical
products; interpretation of clinical results; prospects for
regulatory approval; market prospects for ENTEREG; 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 Form 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 http://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.
GSK Cautionary statement regarding forward-looking
statements
Under the safe harbor provisions of the U.S. Private Securities
Litigation Reform Act of 1995, the company cautions investors that
any forward-looking statements or projections made by the company,
including those made in this Announcement, are subject to risks and
uncertainties that may cause actual results to differ materially
from those projected. Factors that may affect the Group's
operations are described under 'Risk Factors' in the 'Business
Review' in the company's Annual Report on Form 20-F for 2008.
This press release is available on the website
http://www.adolor.com.
Contact: Adolor Corporation Lizanne Wentz (484) 595-1500
GlaxoSmithKline Ken Inchausti (215) 751-4294
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