Adolor Provides Entereg(R) (Alvimopan) Hospital Registration Update
Over 500 Hospitals Have Registered in the E.A.S.E.(TM) Program
EXTON, Pa., Jul 24, 2008 (BUSINESS WIRE) -- Adolor Corporation (NASDAQ:ADLR) announced today that over 500
hospitals have now enrolled in the Entereg Access Support & Education
(E.A.S.E.(TM)) Program. The Company estimates that these hospitals
perform approximately 20% of the annual bowel resection procedures in
the United States. The E.A.S.E. Program was launched by Adolor and
GlaxoSmithKline (NYSE:GSK) in June 2008, following approval of
Entereg(R) (alvimopan) capsules by the U.S. Food and Drug
Administration in May.
"We are delighted with the interest of the hospital community in
Entereg," said Michael R. Dougherty, president and chief executive
officer of Adolor Corporation. "The receptivity shown to the E.A.S.E.
Program has exceeded all early expectations. Entereg is the only
product approved for the management of postoperative ileus with the
demonstrated ability to accelerate GI recovery following bowel
resection surgery. We will continue to work closely with our
colleagues at GSK on the launch of Entereg."
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 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.(TM) 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 0.5 mg twice daily compared with
placebo-treated patients in a 12-month study of patients being treated
with opioids for chronic pain. In this study, the majority of
myocardial infarctions occurred between one and four 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.
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 hospitals,
even though registered in the E.A.S.E. Program, do not purchase
ENTEREG; 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 remains 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 Adolor'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.
References
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.
3. Based on data from Premier
SOURCE: Adolor Corporation
Adolor Corporation Lizanne Wentz, Corporate Communications, 484-595-1500 or Sam Brown Inc. (Media) Mike Beyer, 773-463-4211
Copyright Business Wire 2008





