Cariprazine success in Phase III study of Relapse in Schizophrenia- Actavis + Gedeon Richter

Gedeon Richter Plc. and Actavis plc announced positive results from a Phase III trial evaluating the efficacy and safety of cariprazine in the prevention of relapse in patients with Schizophrenia. There were 101 patients randomized to cariprazine 3 to 9 mg per day and 99 randomized to placebo. The primary efficacy measure was time to first relapse during the double-blind period. There were 25 relapses (24.8%) in the cariprazine group versus 47 relapses (47.5%) in the placebo group. Treatment with cariprazine was associated with a 55% reduction in risk of relapse versus placebo (hazard ratio 0.45, 95% CI [0.28, 0.73] p=0.0010).

Comment:A possible approach for cariprazine is to explore its cognitive effects.Schizophrenia and Bipolar Disorder are associated with cognitive deficits and there is evidence of the involvement of the D3 receptor in cognitive processes. The drug will face strong generic competition as Seroquel and Zyprexa generic versions are entering the market.