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12:00 AM
Apr 16, 2007
 |  BioCentury  |  Product Development

A thousand cuts

FDA has already delayed approval of Entereg alvimopan in the short-term treatment setting of post-operative ileus after seeing a cardiovascular safety signal in six-month data from a Phase III in a chronic indication, opioid-induced bowel dysfunction. Last week, despite reporting 12-month data from the same OIBD study showing increases in both cardiovascular adverse events and neoplasms, Adolor Corp. and partner GlaxoSmithKline plc said they still hope to get the agent approved for POI this year.

Their hypothesis is that the shorter treatment time plus the lack of a safety signal in POI patients will trump any reservations FDA may have about Entereg's long-term safety. The companies have not offered a hypothesis for the cause of the AEs in OIBD.

In trials to treat POI following bowel resection surgery, patients were given 12 mg Entereg twice daily for seven days. In the Phase III OIBD trial (Study 014), 0.5 mg Entereg was given...

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