Phase 3 Trial Update of Cariprazine for Schizophrenia

Forest Laboratories and Gedeon Richter Plc announced results from two Phase 3 clinical trials of cariprazine (RGH-188) for the treatment of acute exacerbation of schizophrenia.

The Fixed-Dose Study, a Phase 3, multinational, multicenter, double-blind, placebo-controlled, parallel-group study, evaluated the efficacy and safety of cariprazine in patients with acute exacerbation of schizophrenia.

The protocol-specified primary endpoint was the change from baseline to Week 6 in the PANSS total score for the individual cariprazine treatment groups compared to placebo treatment using a mixed-effects model for repeated measures (MMRM) analysis. Statistically significant improvement in PANSS total score was observed in each of the cariprazine dose groups relative to the placebo treatment group (3mg/day: -6.0, P=0.0044 and 6mg/day: -8.8, P<0.0001) by MMRM analysis. The change from baseline in PANSS total score was statistically significant at every time point starting at week 1 for the cariprazine 6 mg/d group and week 3 onwards for the cariprazine 3 mg/d group. Statistically significant improvements were also seen in the aripiprazole group relative to placebo in the PANSS total score at each week.

The Fixed-Flexible Dose Study, a Phase 3, multinational, multicenter, double-blind, placebo controlled, parallel-group study, evaluated the efficacy and safety of cariprazine in patients with acute exacerbation of schizophrenia.

The protocol-specified primary endpoint was the change from baseline to week 6 in the PANSS total score for each cariprazine treatment group compared to placebo treatment using the MMRM analysis. Statistically significant improvement in PANSS total score was observed in each of the cariprazine dose groups relative to the placebo treatment group (3-6mg/day: -6.8, P=0.0029 and 6-9mg/day: -9.9, P< 0.0001) by MMRM analysis. The change from baseline was statistically significant at every time point starting at week 1 for the cariprazine 6-9mg/d group and week 2 onward for the cariprazine 3-6mg/d group.

Cariprazine (RGH-188) is an investigational, orally active, potent dopamine D3-preferring D3/D2 receptor partial agonist. In addition, cariprazine has a low potency at other receptor sites, such as 5-HT2C, histamine H1, muscarinic, and adrenergic receptor sites, which have been associated with adverse events.

For more information, call (800) 678-1605 or visit www.frx.com.