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12:00 AM
Nov 13, 2006
 |  BioCentury  |  Product Development

Entereg's safety surprise

A slight excess of serious cardiovascular events in patients receiving Entereg alvimopan in a six-month interim review of data from a safety trial prompted FDA to issue a second approvable letter last week asking for 12-month safety data. The problem for Adolor Corp. and partner GlaxoSmithKline plc is that the ongoing trial wasn't designed to answer questions about cardiovascular safety. Thus, it's unclear how and when the companies are going to get the data that FDA wants.

The companies are seeking approval of oral Entereg 12 mg twice daily for seven days to treat postoperative ileus (POI). The ongoing safety trial that raised a red flag is Study 767905/014, a 12-month Phase III study of 0.5 mg twice daily Entereg to treat...

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