Schizophrenia Drug Shows Promise in Late-Stage Trial

Gedeon Richter and Actavis today announced positive results from a phase 3 trial evaluating the efficacy and safety of cariprazine, an investigational atypical antipsychotic, in preventing relapse among schizophrenia patients.

Gedeon Richter and Actavis today announced positive results from a phase 3 trial evaluating the efficacy and safety of cariprazine, an investigational atypical antipsychotic, in preventing relapse among schizophrenia patients.

The 97-week, multinational, multi-center, randomized, double-blind, placebo-controlled clinical trial enrolled 200 schizophrenia patients, 101 of whom received 3 mg, 6 mg, or 9 mg of cariprazine per day, while the remaining 99 were given placebo.

By the end of the study, the research team found 25 relapses (24.8%) in the cariprazine group, versus 47 relapses (47.5%) in the placebo group. Overall, cariprazine use was associated with a 55% reduction in risk of relapse compared with placebo.

“We are pleased with the long-term efficacy results demonstrated in this trial” said Actavis Senior Vice President David Nicholson in a press release. “Cariprazine has the potential to provide patients suffering with schizophrenia a treatment that can reduce the risk of relapse associated with this serious illness.”

“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.

The most common adverse events experienced by patients treated with cariprazine (incidence >/=5% and greater than placebo) were nasopharyngitis, tremor, extrapyramidal disorder, akathisia, back pain, and increased creatine phosphokinase levels.