EnteregÂ® (alvimopan) capsules is now available to registered hospitals for helping patients recover gastrointestinal (GI) function earlier following bowel resection surgery. Entereg was approved by the U.S. Food and Drug Administration (FDA) on May 20, 2008, and is the first FDA-approved treatment for postoperative ileus (POI), a condition that affects almost all patients undergoing this type of surgery.1 POI can cause significant discomfort for patients in addition to prolonging hospital stays.1 Entereg is for short-term use only in hospitals that perform bowel resections and are enrolled in the Entereg Access Support & Education (E.A.S.E.Â„) Program.
Entereg, a peripherally acting mu-opioid receptor (PAM-OR) antagonist, is indicated to accelerate upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis.
Entereg is the only approved product with a demonstrated ability to accelerate GI recovery following bowel resection surgery, said Michael R. Dougherty, president and chief executive officer of Adolor Corporation. POI is a serious condition that can have negative consequences for patients, and impose considerable expense on the healthcare system. We are working closely with GlaxoSmithKline to enroll hospitals across the United States to make Entereg available to bowel resection surgical teams and patients.
Opioid pain relievers have a role in inhibiting bowel function and motility. POI is associated with abdominal distension and bloating, persistent abdominal pain, nausea and vomiting, 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.2
Opioid analgesics, such as morphine, are widely used for the treatment of postoperative pain. Entereg works by binding to mu-opioid receptors in the gut, selectively inhibiting the negative effects of opioid medications on GI function and motility without reversing central analgesic effects of the opioids.
Entereg is for short-term hospital use only. 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.
Enrollment in the E.A.S.E.Â„ Program
Entereg is available only to hospitals that perform bowel resections and are enrolled in the 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. Hospitals that have reviewed the E.A.S.E. 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 directly from the wholesalers and shipped to the hospital pharmacy.
Important Safety Information About Entereg
The Entereg full prescribing information has a boxed warning that states Entereg is available only for short-term (15 doses) use in hospitalized patients. Only hospitals that have registered in and met all the requirements of 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.
There were more reports of myocardial infarctions in patients treated with alvimopan 0.5Â mg twice daily compared with placebo-treated patients in a 12-month study of patients being treated with opioids for chronic pain. 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.
Overall, the incidence of adverse events in short-term surgical clinical trials was similar between patients receiving either Entereg or placebo. In clinical studies, the most common adverse reactions in patients receiving Entereg following bowel resection were anemia, dyspepsia, hypokalemia, back pain, and urinary retention.
For more information about Entereg, including full prescribing information, 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. By applying its knowledge and expertise in pain management, along with ingenuity, Adolor is seeking to make a positive difference for patients, caregivers and the medical community. For more information, visit www.adolor.com.
Adolor Forward-Looking Statements
This release, and oral statements made with respect to information contained in this release, may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those which express plan, anticipation, intent, contingency, goals, targets or future development and/or otherwise are not statements of historical fact. These statements are based upon management’s current expectations and are subject to risks and uncertainties, known and unknown, which could cause actual results and developments to differ materially from those expressed or implied in such statements. Such known risks and uncertainties relate to, among other factors: the risk that Entereg may not be a commercial success; the uncertainty of market acceptance of Entereg, including acceptance by hospitals, physicians, payors or the medical community; the risk that the Risk Evaluation and Mitigation Strategy or REMS, including the registration of hospitals could materially adversely affect the commercial prospects for ENTEREG or negatively impact the uptake of Entereg, the risks associated with government regulations relating to marketing and selling pharmaceutical products; the risk of product liability claims; the risks of reliance on third party manufacturers; the risk of competitive products; the risk that the alvimopan Investigational New Drug Application (IND) for OBD remain on clinical hold indefinitely; the risk that Entereg may not be approved in OBD or any indication other than the FDA approved indication in bowel resection surgery; the risk that filing targets for regulatory submissions are not met; the risk that the results of other clinical trials of Adolor’s drug products and drug product candidates, including ENTEREG, are not positive or do not support safety or efficacy; the costs, delays and uncertainties inherent in scientific research, drug development, clinical trials and the regulatory approval process; the changing regulatory environment; risks associated with intellectual property protection for AdolorÂ™s products and third party intellectual property; Adolor’s history of operating losses since inception and its need for additional funds to operate its business; Adolor’s reliance on its collaborators, including GSK, in connection with the development and commercialization of ENTEREG; market acceptance of Adolor’s products, if regulatory approval is achieved; competition; and securities litigation.
Further information about these and other relevant risks and uncertainties may be found in Adolor’s 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 in the SEC EDGAR database at http://www.sec.gov and from Adolor at http://www.adolor.com. Given the uncertainties affecting pharmaceutical companies in the development stage, you are cautioned not to place undue reliance on any such forward-looking statements, any of which may turn out to be wrong due to inaccurate assumptions, unknown risks, uncertainties or other factors. Adolor undertakes no obligation to (and expressly disclaims any such 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.
This press release is available on the website http://www.adolor.com.
1. Person B, Wexner SD. The management of postoperative ileus. Curr Prob Surg. 2006;43:12-65.
2. Holte K, Kehlet H. Postoperative ileus: a preventable event. British Jrl Sur. 2000;87:1480.
Sam Brown Inc.
Mike Beyer, 773-463-4211