Adolor Provides Entereg(R) (Alvimopan) Hospital Registration Update
2008-07-24 06:30:00
Adolor Provides Entereg(R) (Alvimopan) Hospital Registration Update
Over 500 Hospitals Have Registered in the E.A.S.E.™
Program
EXTON, Pa.–(EMWNews)–Adolor Corporation (NASDAQ:ADLR) announced today that over 500 hospitals
have now enrolled in the Entereg Access Support & Education (E.A.S.E.™)
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®
(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.™ 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
Adolor Corporation Communications, 484-595-1500 Beyer, 773-463-4211 |
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