Gedeon Richter, Actavis report positive top line results from cariprazine Phase III trial

Gedeon Richter Plc. and Actavis plc (NYSE: ACT) today 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).

"We are pleased with the long-term efficacy results demonstrated in this trial. Cariprazine has the potential to provide patients suffering with schizophrenia a treatment that can reduce the risk of relapse associated with this serious illness," said David Nicholson, Actavis Senior Vice President, Global Brands R&D.

"We are encouraged by the positive top line results shown in this study, which are considered as a further milestone in the process of making this promising treatment option available for patients suffering from schizophrenia," added Dr. Istvan Greiner, Research Director of Gedeon Richter Plc.