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Investigational schizophrenia drug, cariprazine safe, efficacious in phase 3 trial

Phase 3 data indicate that cariprazine was safe and efficacious in the prevention of relapse in patients with schizophrenia, according to a press release issued by Actavis.

The 97-week trial included 101 patients who were randomly assigned to the investigational dopamine D₃/D₂ receptor partial agonist atypical antipsychotic, cariprazine (Gedeon Richter and Actavis) 3-mg or 9-mg, and 99 patients who were randomly assigned to placebo.

Researchers reported 25 relapses (24.8%) in the cariprazine group compared with 47 relapses (47.5%) in the placebo group, according to the press release.

Those assigned to cariprazine demonstrated a 55% reduced risk for relapse compared with those assigned to placebo (HR=0.45; 95% CI, 0.28-0.73), according to the release.

The most common adverse events included: nasopharyngitis, tremor, extrapyramidal disorder, akathisia, back pain, and increased blood creatine phosphokinase.

Cariprazine is currently being investigated for the treatment of bipolar depression and as adjunctive treatment for major depressive disorder in adults, according to the press release.