FDA postpones Entereg action

Adolor (NASDAQ:ADLR) said FDA will not issue an action letter on an NDA for Entereg alvimopan by Saturday, the application's PDUFA date. Adolor did not give a reason for the delay but did say the agency told the company it expects to issue the letter "shortly." Adolor is seeking approval of the mu opioid receptor antagonist, which is partnered with GlaxoSmithKline (LSE:GSK; NYSE:GSK), for postoperative ileus (POI).

In February, FDA extended the PDUFA date for the NDA by three months to May 10 from Feb. 10. In January, an FDA panel voted that the benefits outweigh the risks of Entereg but recommended that the risk management plan be beefed up (See BioCentury, Jan. 28, 2008). ...