Forest and Richter report on bipolar trial

USA-based pharmaceutical company Forest Laboratories and Hungarian drugmaker Richter Gedeon reported preliminary top-line results from a Phase II study of RGH-188 (cariprazine), an investigational antipsychotic, in patients with acute mania caused by bipolar I disorder.

The double-blind, placebo-controlled, flexible-dose five-week study of 236 patients evaluated the safety, efficacy and tolerability of cariprazine monotherapy in patients with acute mania associated with bipolar I disorder.

The primary, protocol-specified, endpoint was change from baseline to week three on the Young Mania Rating Scale, using last observation carried forward analyses. Statistically-significant improvement was noted in patients receiving cariprazine (3mg/day-12mg/day) relative to those given placebo on the YMRS scale (-15.0 cariprazine vs -8.9 placebo, p<0.0001). Statistically-significant improvement was also noted in the mixed-model repeated measure analysis (-15.5 cariprazine vs -8.5 placebo, p<0.0001) as well as the observed-cases analysis (-19.1 cariprazine vs -13.6 placebo, p<0.0001).