Cariprazine: Phase IIb data
Top-line data from an 8-week, double-blind, international Phase IIb trial in 584 patients ages 18-65 with depressive episodes of bipolar I disorder showed that once-daily 1.5 mg oral cariprazine met the primary endpoint of reducing MADRS total score from baseline to week 6 vs. placebo. Specifically, mid-dose cariprazine reduced MADRS from baseline to week 6 by 4 points over placebo (p=0.003). The once-daily 0.75 and 3 mg doses of cariprazine missed the primary endpoint (1.9 and 2.5 point reductions over placebo, respectively, p=0.1292 and p=0.1122). Mid-dose cariprazine also met the secondary endpoint of reducing CGI-S score from baseline to week 6 vs. placebo (0.4 point reduction over placebo, p=0.0132), but low- and high-dose cariprazine missed the secondary endpoint (0.1 and 0.3 point reductions over placebo, respectively, p=0.3025 and p=0.1122). Across all cariprazine dose groups, the most common adverse events were akathisia and insomnia.
Last month, Forest reported top-line data from a Phase IIb trial in 819 patients with major depressive disorder (MDD) who had an inadequate response to antidepressant therapy showing that adjunctive treatment with oral cariprazine dosed flexibly at 2-4.5 mg/day met the primary endpoint of reducing MADRS total score from baseline to week 8 vs. placebo (see BioCentury, March 24). Forest said it plans to present data from both trials at an end-of-Phase II meeting with FDA "as soon as possible" to finalize a Phase III depression program for cariprazine. ...