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Sep 11, 2006
 |  BioCentury  |  Product Development

Entereg piles up uncertainty

Entereg piles up uncertainty

Entereg piles up uncertainty
Last week, Adolor Corp. (ADLR, Exton, Penn.) and GlaxoSmithKline plc (LSE:GSK; GSK, London, U.K.) reported mixed topline results from a pair of double-blind, placebo-controlled Phase III trials of Entereg alvimopan in opioid-induced bowel dysfunction, its second most advanced indication. This is not the first time Entereg came up with a mixed bag: Phase III results in postoperative ileus also were inconsistent. The partners will soon see how FDA interprets those data, as an NDA for the oral, non-absorbed, gastrointestinal-restricted mu-opioid receptor antagonist to treat POI has a Nov. 9 PDUFA date.
The primary endpoint of both OBD studies was the proportion of patients who had a weekly average of three or more spontaneous bowel movements (SBM) and an increase from baseline of one or more SBMs a week over the 12-week treatment...

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