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Adolor Corporation (Nasdaq:ADLR) announced today that the U.S. Food and Drug Administration (FDA) has communicated to the company that it will not be issuing an action letter on the NDA for Entereg(R) (alvimopan) for postoperative ileus by May 10, 2008, the scheduled PDUFA date
EXTON, PA, USA | May 9, 2008 | Adolor Corporation (Nasdaq:ADLR) announced today that the U.S. Food and Drug Administration (FDA) has communicated to the company that it will not be issuing an action letter on the NDA for Entereg(R) (alvimopan) for postoperative ileus by May 10, 2008, the scheduled PDUFA date. The FDA did not provide a specific date, but informed the company that it expects to issue the action letter shortly.
Adolor is seeking marketing approval of Entereg for the proposed indication to accelerate upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis.
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(R) (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.
SOURCE: Adolor Corporation |
