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More mixed Entereg data

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

GSK and Adolor announce initial top-line results from two Phase II studies of the peripheral mu opioid receptor antagonist Entereg (alvimopan) March 7, one positive and one failed. Entereg was statistically significant for all doses for all endpoints in a Phase IIb study (011) in 522 non-cancer patients with opioid-induced bowel dysfunction. A Phase IIa proof-of-concept study (007) in chronic idiopathic constipation not due to opioid treatment, however, failed to show significant difference from placebo for any dose on any endpoint. "Exploratory analyses of these data...suggest that some constipated patients may have achieved therapeutic benefits and so further studies are being considered," the firms said. GSK/Adolor's Entereg NDA for treatment of post-operative ileus is based on mixed trial results. Entereg has an April 25 action date, but the firms are expecting a 90-day extension following submission of FDA-requested data (1Pharmaceutical Approvals Monthly January 2005, p. 36)...
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