Cariprazine: Preliminary Phase IIb data
Top-line data from a double-blind, placebo- and active-controlled Phase IIb trial in 732 subjects showed that 1.5, 3 and 4.5 mg/day cariprazine met the primary endpoint of significantly improving symptoms of schizophrenia as measured by change on PANSS from baseline to week 6 vs. placebo (7.5, 8.9 and 10.4 point decreases, respectively, p<0.001 for each). Each dose also met the secondary endpoint of significantly improving treatment response on CGI-S at week 6 vs. placebo. Cariprazine was well tolerated. There were more patients in the placebo group who discontinued due to adverse events than in the 1.5, 3 and 4.5 mg/day cariprazine groups (15% vs. 10%, 5% and 8%, respectively). Risperdal risperidone, which was used as a positive control, also significantly improved PANSS and CGI-S vs. placebo. ...