Cariprazine: Phase IIb data
Top-line data from a double-blind, international Phase IIb trial in 819 MDD patients ages 18-65 who had an inadequate response to antidepressant therapy showed 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. Specifically, 2-4.5 mg daily cariprazine reduced MADRS from baseline to week 8 by 2.2 points over placebo (p=0.0114). Cariprazine dosed flexibly at 1-2 mg/day missed the primary endpoint (0.9 point reduction over placebo, p=0.2404). Across both cariprazine dose groups, the most common adverse events were akathisia, nausea, insomnia, somnolence and fatigue. Early next year, Forest plans to start a Phase III trial with cariprazine to treat MDD. ...