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12:00 AM
Jan 19, 2004
 |  BioCentury  |  Product Development

Digesting Entereg

Being the first to market in a disease area has its advantages, but getting there can mean taking the regulatory road less traveled. Despite having won, lost and drawn in their three Phase III trials in post-operative ileus, Adolor Corp. and partner GlaxoSmithKline plc (LSE:GSK; GSK, London, U.K.) are pressing forward with the Entereg alvimopan NDA based on what they feel is a good risk/benefit profile.

In the third and last Phase III efficacy trial (14CL308) reported last week, both the 6 mg and 12 mg Entereg doses failed to improve the primary endpoint - time to recovery of both upper and lower gastrointestinal (GI) function - compared to placebo (see "Entereg Overview").

On the other...

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