Forest's cariprazine mixed in bipolar trial

Forest Laboratories Inc. (NYSE:FRX) reported mixed data from a 584-patient Phase IIb trial evaluating once-daily oral cariprazine to treat patients with depressive episodes of bipolar I disorder. A 1.5 mg dose of cariprazine met the primary endpoint of reducing Montgomery-Asberg Depression Rating Scale (MADRS) total score from baseline to week six vs. placebo (p=0.003), but 0.75 and 3 mg doses of cariprazine missed the primary endpoint.

Earlier this month, Forest said 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 eight vs. placebo in a Phase IIb trial in major depressive disorder (MDD) patients. 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 (see BioCentury Extra, March 21). ...