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Schizophrenia Drug Cariprazine Shows Promise in Phase III Study

Risk of relapse reduced by half compared with placebo

Positive results have been reported from a phase III trial evaluating the efficacy and safety of cariprazine (Gedeon Richter/Actavis) in the prevention of relapse in patients with schizophrenia.

Cariprazine, an investigational drug, is a dopamine D3/D2 receptor partial-agonist atypical antipsychotic with preferential binding to D3 receptors for the treatment of patients with schizophrenia and for adult patients with manic or mixed episodes associated with bipolar I disorder. The safety and efficacy of cariprazine were studied in a clinical trial program involving more than 2,700 adult patients. In addition, cariprazine is being investigated for the treatment of bipolar depression and as adjunctive treatment for major depressive disorder in adults.

The new phase III trial was a 97-week, multinational, randomized, double-blind, placebo-controlled study in 200 adults with schizophrenia. The study included a 20-week open-label phase, during which the patients were treated with cariprazine 3, 6, or 9 mg/day. Patients who responded to these regimens and met the study’s stabilization criteria during the open-label period were randomly assigned to continue their cariprazine dose (3, 6, or 9 mg/day; n = 101) or were switched to placebo (n = 99) for up to 72 weeks or until relapse occurred. The study’s primary endpoint was the time to first symptom relapse during the double-blind phase.

Twenty-five relapses (24.8%) occurred in the cariprazine group compared with 47 (47.5%) in the placebo group. Treatment with cariprazine was associated with a 55% reduction in the risk of relapse compared with placebo (hazard ratio, 0.45; P = 0.0010).

In the cariprazine group, the most common adverse events included nasopharyngitis, tremor, extrapyramidal disorder, akathisia, back pain, and increased blood creatine phosphokinase levels.

Schizophrenia affects more than 2 million people in the U.S. and imposes a significant burden on patients, their families, and society. The symptoms of schizophrenia fall into three broad categories: positive symptoms (e.g., hallucinations, delusions, thought disorders, and movement disorders); negative symptoms (e.g., the loss of motivation and social withdrawal); and cognitive symptoms (e.g., problems with executive functioning, focusing, and working memory).

Source: PipelineReview; January 20, 2015.


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