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news.Wyeth and Progenics Pharmaceuticals have announced preliminary findings from the first of two Phase III clinical trials of intravenous methylnaltrexone being evaluated for the management of postoperative ileus, in patients recovering from segmental colectomy surgical procedures.
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Preliminary results from the Phase III clinical trial conducted by Wyeth showed that treatment did not achieve the primary end point of the study – a reduction in time to recovery of gastrointestinal function as compared to placebo.
The study also did not show that secondary measures of surgical recovery, including time to discharge eligibility, were superior to placebo. In this clinical study, methylnaltrexone was administered intravenously in doses of 12 or 24mg every six hours and was generally well tolerated.
Paul Maddon, Progenics’s founder, CEO, and chief scientific officer, said: “Currently, we are conducting the necessary analyses to determine greater clarity regarding the outcome of this clinical study.”