EXTON, PA and PHILADELPHIA, PA--(Marketwire - August 20, 2009) - 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.
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.™)
Program. This program is designed to maintain the benefits associated with
short-term use in the bowel resection population and prevent long-term,
WARNING: FOR SHORT-TERM HOSPITAL USE ONLY
ENTEREG is available only for short-term (15 doses) use in hospitalized
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
ENTEREG is contraindicated in patients who have taken therapeutic doses of
opioids for more than 7 consecutive days immediately prior to taking
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
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
* Dr. Timothy Beard is a member of the Speakers' Bureau for Adolor and
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.
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