Salix Pharmaceuticals, Ltd. (SLXP) and Progenics Pharmaceuticals, Inc. (PGNX) announced the successful outcome of the Phase 3 trial to assess the efficacy and safety of oral methylnaltrexone for treating opioid-induced constipation in subjects with chronic, non-cancer pain.
The trial, evaluating three once-daily oral methylnaltrexone dosing regimens, showed highly statistically significant results for the primary endpoint in two of the three treatment arms versus placebo treatment arm. Both the 300 and 450 mg treatment arms demonstrated highly statistically significant improvements in rescue-free bowel movement, or RFBM, within 4 hours of administration over 28 days of dosing when compared to placebo treatment.
Also, the 300 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. Statistically significant efficacy was also seen in both the 300 and 450 mg treatment groups for the two key secondary efficacy endpoints.
Salix stated that overall, efficacy of oral methylnaltrexone in the study was comparable to that reported in clinical studies of subcutaneous methylnaltrexone in subjects with chronic, non-cancer pain. The overall observed safety profile seen in patients treated with oral methylnaltrexone was comparable to placebo in the study, the company added.
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