Phase 3 Study of Methylnaltrexone for Opioid-Induced Constipation
Salix and Progenics announced results from its Phase 3 study of oral methylnaltrexone for the treatment of opioid-induced constipation (OIC) in subjects with chronic, non-cancer pain. This trial evaluated three once-daily oral methylnaltrexone dosing regimens (150mg, 300mg, and 450mg) and demonstrated statistically significant results for the primary endpoint in two of the three treatment arms when compared to the placebo arm.
Both the 300mg and 450mg treatment arms demonstrated highly statistically significant improvements in rescue-free bowel movement (RFBM) within 4 hours of administration over 28 days of dosing when compared to placebo treatment. In addition, the 300mg and 450 mg treatment arms demonstrated highly statistically significant improvements in RFBM within 4 hours of administration following the first dose when compared to placebo treatment.
The efficacy of oral methylnaltrexone in this study was comparable to that reported in clinical studies of subcutaneous methylnaltrexone (Relistor; Salix) in subjects with chronic, non-cancer pain.
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