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news.Wyeth Pharmaceuticals, a division of Wyeth, and Progenics Pharmaceuticals have reported preliminary results from two clinical trials conducted with investigational oral and intravenous formulations of Relistor.
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The first of these studies, a Phase II trial, evaluated the effects of an oral formulation of Relistor for the treatment of opioid-induced constipation (OIC), in patients with chronic, non-malignant pain. This study showed positive activity.
The second study, a Phase III trial, examined the use of an intravenous formulation of Relistor for post-operative ileus (POI). In this study, the drug did not meet its primary or secondary end points.
The study of the Relistor oral formulation was a double-blind, randomized, placebo-controlled Phase II trial. In this four-week trial of 122 patients with chronic, non-malignant pain who were receiving opioids for pain management, the once daily oral formulation of Relistor showed statistically significant activity as assessed by the occurrence of spontaneous bowel movements and other efficacy measures.
The Progenics-conducted Phase III study of an intravenous formulation of Relistor for patients with POI did not meet the primary or secondary end points, confirming the earlier findings of the Wyeth Phase III intravenous POI study announced on March 12, 2008.
Progenics and Wyeth will now study the results of both Phase III intravenous POI studies to determine whether and how to continue development of this formulation of Relistor and this indication.