Cariprazine: Phase III data
Top-line data from a double-blind, international Phase III trial in 497 patients aged 18-65 years with acute mania associated with bipolar I disorder showed that 3-6 mg/day and 6-12 mg/day oral cariprazine each met the primary endpoint of significantly reducing YMRS scores from baseline to week 3 vs. placebo. Specifically, low- and high-dose regimens of cariprazine led to reductions of 6.1 and 5.9 points relative to placebo, respectively (p<0.001 for both). Cariprazine was generally well tolerated with akathisia and constipation reported as the most common adverse events. Last October, the partners reported top-line data from a U.S. and Indian Phase III trial in 312 patients aged 18-65 with acute mania associated with bipolar I disorder showing that cariprazine met the same primary endpoint vs. placebo (19.6 vs. 15.3 points, p<0.001) (see BioCentury, Oct. 10, 2011). ...