Methylnaltrexone enters Ph II OIC study

USA-based drug makers Wyeth Pharmaceuticals and Progenics Pharmaceuticals say they have initiated a Phase II trial of the co-developed opioid-induced constipation treatment methylnaltrexone. Specifically, the program is a dose-ranging study, designed to evaluate once-daily, oral administration of the drug in OIC sufferers who are receiving opioid-based treatment for chronic pain.

The trial will take place at more than 100 sites in 21 countries, and is expected to recruit between 200 and 400 subjects. Additionally, following discussions with the US Food and Drug Administration, the firms have elected to employ an adaptive approach to the assessment in order to expedite the selection of the most efficacious dose, for use in Phase III studies scheduled for 2007.