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FDA Requests Entereg Failed European Study Data, Adolor Says

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA requests Entereg failed European study data, Adolor reports. Alvimopan failed to show statistical significance for the primary endpoint in partner GlaxoSmithKline’s Phase III study. The pending NDA for the postoperative ileus therapy is based on three studies with mixed results

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Adolor Entereg Reduces Hospital Stays By 18 Hours, FDA-Requested Study Finds

GlaxoSmithKline/Adolor's postoperative ileus agent Entereg provides a statistically significant reduction in length of hospital stay, according to trial results reported by Adolor Feb. 7

GSK/Adolor Entereg NDA extension

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)...

More mixed Entereg data

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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