Study Published In Archives Of Surgery Demonstrated Benefit Of Entereg (Alvimopan) In Postoperative Ileus
Study Reports that ENTEREG(R) Accelerated GI Recovery and Shortened Length of Stay in Patients Undergoing Partial Small or Large Bowel Resection with Primary Anastomosis -
EXTON, Pa. & PHILADELPHIA, Nov 18, 2008 (BUSINESS WIRE) -- Adolor Corporation (NASDAQ:ADLR) and GlaxoSmithKline (NYSE:GSK) announced today that the Phase 3 Study 14CL314 of ENTEREG(R) (alvimopan) for the management of postoperative ileus (POI) has been published in the November issue of Archives of Surgery, the official publication of the New England Surgical Society, the Pacific Coast Surgical Association and the Western Surgical Association. This study demonstrated that ENTEREG accelerated the time to recovery of gastrointestinal (GI) function, shortened length of hospital stay and reduced POI-related morbidity following bowel resection surgery in the patients studied.
POI, a serious condition affecting almost all patients undergoing bowel resection surgery, can cause significant discomfort for patients and imposes expense on the health care system. ENTEREG is the first and only product approved by the U.S. Food and Drug Administration for the management of POI. ENTEREG is indicated to accelerate upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis.
"The publication of this study adds to the literature confirming meaningful benefits of alvimopan to patients for the management of POI, a common post-surgical disorder," commented Conor Delaney, M.D., Ph.D., professor and chief, Division of Colorectal Surgery, vice-chairman, Department of Surgery of Case Western Reserve University, University Hospitals of Cleveland and an investigator in the study.
About the Phase 3 Study
Study 14CL314, a multi-center, randomized, placebo-controlled, double-blind, Phase 3 trial, investigated the efficacy and safety of ENTEREG in conjunction with a standardized accelerated postoperative care pathway (early ambulation, oral feeding and postoperative nasogastric tube removal) for managing POI following bowel resection surgery. The study enrolled 654 bowel resection patients, randomized into two arms to receive either placebo or 12 mg of ENTEREG twice daily. ENTEREG accelerated the time to recovery of GI function and reduced the time to hospital discharge order written as compared to placebo. ENTEREG did not reverse opioid analgesia in these patients.
About Postoperative Ileus
Postoperative ileus or (POI) is the impairment of gastrointestinal (GI) motility after intra-abdominal surgery or other non-abdominal surgeries. It is associated with abdominal distension and bloating, persistent abdominal pain, nausea and vomiting, variable reduction of bowel sounds, delayed passage of or an inability to pass flatus (gas) or stool, and an inability to tolerate oral intake or progress to a solid diet. POI affects all segments of the GI tract and may last from 5 to 6 days, or even longer. This may potentially delay GI recovery and hospital discharge until its resolution.
ENTEREG is a peripherally acting mu-opioid receptor (PAM-OR) antagonist. The benefits of ENTEREG were demonstrated in five clinical studies, including Study 314. These studies enrolled more than 2,500 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 (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. Hospitals that have reviewed the E.A.S.E. Program educational materials and have systems in place to limit the use of ENTEREG to no more than 15 doses per patient can enroll at www.entereg.com. Upon enrollment, ENTEREG can be ordered through the wholesalers, and will be drop-shipped directly to the hospital pharmacy.
Important Safety Information
Warning: For Short-Term Hospital Use Only
ENTEREG is available only for short-term (15 doses) use in
Only hospitals that have registered in and met all of the
requirements for the ENTEREG Access Support & Education (E.A.S.E.(TM))
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.
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.
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.
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, including the results of the 14CL314 study and the benefits of ENTEREG for the management of POI; 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 2007.
SOURCE: Adolor Corporation
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Posted: November 2008