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FDA Lifts Clinical Hold on OBD IND
EXTON, PA, USA | July 3, 2008 | Adolor Corporation (Nasdaq: ADLR) today issued an update on the Entereg(R) (alvimopan) Program for chronic opioid bowel dysfunction (OBD), under development in collaboration with GlaxoSmithKline (NYSE: GSK).
The U. S. Food and Drug Administration (FDA) has concluded that clinical investigations relating to alvimopan in OBD may now proceed, and has therefore lifted the clinical hold on the OBD Investigational New Drug Application.
"After a productive meeting and dialogue with FDA, we are very pleased to see the clinical hold lifted," said Michael R. Dougherty, president and chief executive officer of Adolor. "There remains a large, unmet need for treatment options for the many patients suffering from this debilitating condition."
Adolor understands that GSK is evaluating all options relating to the OBD Program, including whether to proceed with its involvement with the Program. The April 2002 Collaboration Agreement between Adolor and GSK provides that GSK may terminate the Agreement with respect to the OBD product, returning rights to the OBD product to Adolor, while retaining its rights to the postoperative ileus (POI) product.
Michael R. Dougherty said, "Should GSK determine to discontinue their involvement with the OBD Program, Adolor would expect to submit for review by FDA a protocol for an additional study in this indication."
GSK and Adolor are actively engaged in the commercialization of the recently approved Entereg for POI for bowel resection surgeries.
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.
SOURCE: Adolor Corporation |
