Source: Lazar Partners

Pharmacoeconomic Analysis of Reported Use of ENTEREG(R) (alvimopan) Published in American Journal of Health-System Pharmacy

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, outpatient use.


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


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

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

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

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 and from Adolor at 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.

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Contact Information: Contact: Adolor Corporation Lizanne Wentz (484) 595-1500 GlaxoSmithKline Ken Inchausti (215) 751-4294