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GSK/Adolor Entereg NDA extension

Executive Summary

FDA extends GlaxoSmithKline/Adolor's Entereg (alvimopan) NDA review for the management of postoperative ileus by three months to July 25. The agency will use the extra time to evaluate additional clinical data. Adolor submitted a failed Phase III clinical trial to FDA earlier this month for the postoperative ileus therapy. FDA requested the study, conducted by GSK, in January. The trial failed to show a statistically significant impact on the time to recovery of gastrointestinal function endpoint (1"The Pink Sheet" Jan. 15, 2005, In Brief)...
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