July 9, 2007
Progenics and Wyeth reported positive results from an open label phase III extension trial of subcutaneous methylnaltrexone (MNTX) for the treatment of opioid-induced constipation (OIC). This three month extension trial enrolled 82 subjects who had completed a previous phase III trial (MNTX 302). Of these subjects, 42 had received subcutaneous methylnaltrexone in the prior trial and 40 had received placebo. Of the subjects who had prior MNTX the mean laxation response rates (laxation within four hours) were 45.5% during the first month, 57.7% in the second month, and 57.3% in the third month. Of the subjects with no prior MNTX experience, laxation response rates were 48.3% during the first month, 47.6% in the second month, and 52.1% in the third month. This long term data were included in the NDA filing currently under review by the FDA.