GlaxoSmithKline and Adolor report favourable FDA Advisory Committee meeting for Entereg® (alvimopan) for the management of postoperative ileus in bowel resection
Issued — Wednesday 23 January 2008, London, UK, Exton & Philadelphia, PA
GlaxoSmithKline and Adolor Corporation (Nasdaq: ADLR) today announced that a majority (9-6) of the Gastrointestinal Drugs Advisory Committee (GIDAC) of the U.S. Food and Drug Administration (FDA) voted that the overall benefits of treatment with Entereg® (alvimopan), an investigational mu-opioid receptor antagonist, outweighed potential risks for short-term, in-hospital use in patients following partial large or small bowel resection surgery with primary anastomosis. The FDA is reviewing Adolor’s New Drug Application (NDA) for Entereg for the proposed indication of acceleration of upper and lower gastrointestinal (GI) recovery following partial large or small bowel resection surgery with primary anastomosis. There are no drugs approved for this indication.
With regard to the specific questions posed by the FDA to the committee, members voted 13-0, with two abstentions, that the efficacy results from the submitted studies in postoperative ileus (POI) were clinically meaningful. Although the panel voted (8 to 6 with one abstention) that a potential cardiovascular risk signal seen in one long-term OBD study (Study 014) remained a concern for short-term use in managing POI, a majority (9-6) agreed that the overall benefits of treatment with alvimopan outweighed the potential risks for short-term in-hospital use in the proposed bowel resection patient population. The panel voted 14 to 0 with one abstention that the preliminary risk management plan proposed by Adolor was not adequate to address potential risks.
“This is an important milestone for Entereg and we are pleased with the favorable outcome of the Committee meeting,” said Michael R. Dougherty, president and chief executive officer of Adolor Corporation. “This is further validation of our confidence in Entereg and our belief in the clinical benefit offered by Entereg in this indication. I would like to commend the significant effort of the combined Adolor and GSK development team. We look forward to working with the FDA, including the further development of a risk management plan, as they complete the review of the NDA for Entereg .”
The Committee’s recommendation, although not binding, will be considered by the FDA as it completes its review of the NDA for Entereg . The Prescription Drugs User Fee Act (PDUFA) action date for the NDA is 10 February 2008.
“A majority of the Committee agreed that Entereg produced clinically meaningful acceleration in GI recovery in bowel resection patients,” said Yvonne Greenstreet, senior vice president of the medicine development centre at GlaxoSmithKline. “Postoperative ileus can be uncomfortable for the patient, hinder post surgical recovery and delay hospital discharge in bowel resection patients. If approved, Entereg would be the first medication to address this common and burdensome complication.”
About GlaxoSmithKline
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.
About Adolor Corporation
Adolor Corporation (Nasdaq: ADLR) is a biopharmaceutical company specializing in the discovery, development and commercialization of novel prescription pain management products. Adolor has two lead product candidates in development: Entereg® (alvimopan) for the management of the gastrointestinal side effects associated with opioid use; and novel Delta opioid receptor agonists for a variety of pain indications. Adolor and GlaxoSmithKline are collaborating in the worldwide development and commercialization of Entereg in multiple indications. Adolor and Pfizer are collaborating in the worldwide development and commercialization of two Delta agonists for pain. Adolor also has a number of discovery research programs focused on the identification of novel compounds for the treatment of pain. 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.
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 www.sec.gov and from Adolor at 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 www.adolor.com.
GlaxoSmithKline Enquiries:
UK Media enquiries: |
Philip Thomson |
(020) 8047 5502 |
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US Media enquiries: |
Nancy Pekarek |
(215) 751 7709 |
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European Analyst/ |
David Mawdsley |
(020) 8047 5564 |
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US Analyst/ Investor |
Frank Murdolo |
(215) 751 7002 |
Adolor Corporation Enquiries:
Corporate Communications |
Lizanne Wentz |
(484) 595 1500 |
Sam Brown Inc. (Media) |
Mike Beyer |
(773) 463 4211 |


