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FDA Pushes Back NDA Review for Alvimopan

EXTON, Pa., April 19 /PRNewswire-FirstCall/ -- Adolor Corporation (NASDAQ:ADLR) announced today that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target action date from April 25, 2005 to July 25, 2005 for the completion of its review of the New Drug Application (NDA) for Entereg (alvimopan) capsules for the management of postoperative ileus (POI).

In January 2005, the FDA requested that the company provide information from the GlaxoSmithKline (GSK) European Phase 3 clinical study (SB-767905/001) of alvimopan in postoperative ileus and the company indicated its goal was to deliver the information in a time frame that would allow for a PDUFA date extension. The final component of the requested information, the clinical study report from GSK Study 001, was submitted to the FDA earlier this month.

Study 001 was conducted by GSK in Europe, Australia and New Zealand. Adolor announced top-line results from Study 001 on December 23, 2004.

About Entereg (alvimopan)
Alvimopan is an investigational peripherally-acting mu opioid receptor antagonist (PAMOR) designed to block the negative effects of opioids, like morphine or codeine, on the gastrointestinal system without interfering with the analgesic effects on the central nervous system. It is the first of this new class with a New Drug Application (NDA) that has been accepted for review by the U.S. Food and Drug Administration (FDA) for postoperative ileus.

Source: Adolor Corporation

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