Two of these trials will investigate the use of subcutaneous methylnaltrexone for treating opioid-induced constipation in patients outside of the palliative care population. The third trial will investigate the use of intravenous methylnaltrexone for managing post-operative ileus in a surgical setting in patients at high risk for post-operative ileus.
The companies are studying intravenous methylnaltrexone in Phase III trials to manage post-operative ileus in patients undergoing segmental colectomy surgical procedures. All of the studies are intended to investigate additional patient populations for methylnaltrexone.
Paul Maddon, founder, CEO and CSO of Progenics, said: “Opioid-induced constipation and post-operative ileus represent important medical needs for which there currently are no approved prescription therapies. Since the beginning of the collaboration, Wyeth and Progenics have made considerable strides in the clinical, regulatory and commercial development of methylnaltrexone. These trials are designed to further our understanding of the compound in opioid-induced constipation and post-operative ileus.”
New drug application submission is planned for intravenous methylnaltrexone for managing post-operative ileus in early 2008 based on the ongoing Phase III studies in patients undergoing segmental colectomy. Additionally, the companies recently announced positive preliminary results from a Phase I clinical trial of a new oral formulation of methylnaltrexone.