Gedeon Richter: Cariprazine demonstrates broad-spectrum antidepressant effects across different patient populations

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Mar 29, 2023, 05:00 ET

BUDAPEST, Hungary, March 29, 2023 /PRNewswire/ -- At the 31^st Annual Meeting of the European Psychiatric Association (EPA), held between 25-28 March 2023 in Paris, France, new analyses of cariprazine studies were presented by Gedeon Richter Plc. The posters provided evidence for the effectiveness of cariprazine in alleviating depressive symptoms in various diagnoses, as well as showed that the effectiveness of cariprazine in improving negative symptoms in schizophrenia is similar in clinical trials and real-world settings. Furthermore, the TRR (Therapeutic Reference Range) of the trough plasma levels was highlighted.

Schizophrenia is a chronic psychiatric disorder characterized by positive, negative, cognitive, and mood symptoms, affecting 1% of the population. Although antipsychotics are effective in the treatment of positive symptoms, the management of negative, cognitive, and affective symptoms often remains challenging.

Depressive symptoms are a common feature of schizophrenia and define major depressive disorder and bipolar disorder, having devastating effects on patients' functioning and quality of life, and increasing the risk of hospitalization and suicide. The first poster provided evidence for the effectiveness of cariprazine in alleviating depressive symptoms in various conditions, including schizophrenia, major depression and bipolar depression – these findings imply that the efficacy of the drug in depressive symptoms is independent of the diagnosis.

Another poster highlighted the increasing need for gathering real-world data in order to understand how the drug works in heterogeneous patient populations, therefore complementing the knowledge gained from clinical trials. To compare the effectiveness of cariprazine in clinical trials vs real-world settings in alleviating negative symptoms in schizophrenia patients, the results of two separate analyses from a clinical trial and an observational study were plotted together to visually compare them. The findings have shown that there was virtually no difference between the results, and negative symptoms improved minimally to much with cariprazine according to both clinical and real-world data.

The 3^rd poster provided details on the examination of the therapeutic reference range (TRR) for cariprazine 1.5 mg/day to 6 mg/day in schizophrenia studies. According to the results, the TRR of the trough plasma levels at steady state is ca. 30 – 100 nM for Total cariprazine, and ca. 2-10 ng/mL for the parent drug (unchanged drug) for schizophrenia treatment.

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