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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