Forest reports data for cariprazine in Phase IIb MDD trial

Forest Laboratories Inc. (NYSE:FRX) said adjunctive treatment with oral cariprazine dosed flexibly at 2-4.5 mg/day met the primary endpoint of reducing Montgomery-Asberg Depression Rating Scale (MADRS) total score from baseline to week eight vs. placebo in a Phase IIb trial to treat major depressive disorder (MDD) (p=0.0114). Cariprazine dosed flexibly at 1-2 mg/day missed the primary endpoint (p=0.2404). The double-blind, international trial enrolled 819 MDD patients ages 18-65 who had inadequate response to antidepressant therapy. Early next year, Forest plans to start a Phase III trial with cariprazine to treat MDD.

Last year, FDA issued a complete response letter for cariprazine to treat schizophrenia and manic or mixed episodes associated with bipolar I disorder in adults. According to Forest, FDA said more information, including additional clinical trial data, was needed. Forest said it plans to meet with FDA and has not yet made any decisions regarding next steps for the schizophrenia or bipolar mania programs (see BioCentury Extra, Nov. 21, 2013). ...