Jan 20 2015
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.
Study aims to identify clinical subtypes in patients with schizophrenia