Crofelemer: Phase III data
Top-line data from the 2-stage, double-blind Phase III ADVENT trial in 374 HIV-positive patients showed that twice-daily 125 mg crofelemer for 28 days met the primary endpoint of significantly increasing the proportion of patients experiencing relief of diarrhea, defined as having <=2 watery stools in 2 of 4 weeks, vs. placebo (p=0.0096). The partners said that due to the adaptive design of the trial, which has an SPA from FDA, the pre-specified p-value for the treatment difference was 0.025. The partners have requested a pre-NDA meeting with FDA in 1Q11. Crofelemer was well tolerated. Stage 1 of the trial evaluated twice-daily 150, 250 and 500 mg doses of crofelemer vs. placebo for 28 days in 200 patients. Following completion of Stage 1, an independent review board selected the 125 mg dose for use in Stage 2 of the trial (see BioCentury, August 17, 2009). ...