Medication Use Evaluation of ENTEREG (alvimopan) Published in the November Edition of The Annals of Pharmacotherapy
EXTON, Pa.--(BUSINESS WIRE)--Nov 3, 2010 - 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.”
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.
SHORT-TERM HOSPITAL USE ONLY
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.
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 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.
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.
Contact: Adolor Corporation
Posted: November 2010