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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 Adolors 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
Lizanne Wentz, Corporate

Communications, 484-595-1500
or
Sam Brown Inc. (Media)
Mike

Beyer, 773-463-4211

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