Oral methylnaltrexone: Phase III data

A double-blind Phase III trial in 804 patients with chronic, non-cancer pain showed that once-daily 300 and 450 mg oral methylnaltrexone each met the primary endpoint of significantly improving the proportion of patients with a RFBM within 4 hours of treatment each day over 28 days vs. placebo. Additionally, mid- and high-dose oral methylnaltrexone significantly improved the proportion of patients with a RFBM within 4 hours of administration of the first dose vs. placebo. Mid- and high-dose oral methylnaltrexone also met the secondary endpoint of significantly increasing the proportion of patients who were considered responders, defined as having >=3 RFBM per week with an increase of >=1 RFBM per week from baseline for >=3 out of the first 4 weeks, vs. placebo. The once-daily 150 mg dose of oral methylnaltrexone missed the primary and secondary endpoints. The overall safety profile of oral methylnaltrexone was comparable to that of placebo. Patients received placebo or once-daily 150, 300 or 450 mg oral methylnaltrexone for 28 days, and then on an as-needed basis for an additional 56 days. ...