Cariprazine significantly reduces agitation and hostility in patients with schizophrenia based on Gedeon Richter Plc's analyses

BUDAPEST, Hungary, Sept. 15, 2020 /PRNewswire/ -- On 12-15 September 2020, during the 33^thAnnual Meeting of the European College of Neuropsychopharmacology (ECNP) – which was held virtually due to the COVID-19 pandemic situation – new analyses of cariprazine studies with schizophrenia patients were presented. Based on the post-hoc analysis of four double-blind trials, cariprazine treatment was found to be effective for agitation and hostility – one of the most critical aspects of schizophrenia – in acute patients. Furthermore, it was also highlighted that patients in the early stage of illness experienced significant improvement with cariprazine. Importantly, cariprazine also improved patient social performance compared to placebo or risperidone, and relapse occurred significantly less often with cariprazine than with placebo, despite the fact that many safety parameters were comparable in the two groups.

Schizophrenia is a chronic psychiatric disorder comprising five symptom domains; positive, negative, cognitive, mood and hostility. It affects about 1% of the population, meaning that an estimated 5 million people struggle with this illness just in the EU. Treatment of schizophrenia is predominantly done by prescribing antipsychotic medication. Choosing the right medication, however, depends not only on the symptoms that the patient experiences, but other factors as well, such as tolerability and the ability to improve everyday functioning. Hence, in the posters presented at the ECNP, the scientific team has focused on those aspects of cariprazine treatment that look beyond the "classic" symptoms of schizophrenia.

Agitation and hostility are critical aspects in the treatment of schizophrenia. Psychotic patients with agitation and hostile behaviour are hospitalized more frequently and for a longer time, as well as have poorer adherence to treatment. Based on evidence of double-blind trials – which are the gold standard in clinical research – cariprazine treatment was efficacious in acute patients for agitation and hostility from week two and one, respectively. In addition, higher levels of baseline severity were associated with a greater effect of cariprazine in these regards.

Besides agitation and hostility, another important aspect of schizophrenia treatment is functioning in everyday life. A post-hoc analysis on the efficacy of cariprazine vs. risperidone/placebo showed that cariprazine is associated with a clinically relevant improvement in patient functioning and social performance, based on changes on the Personal and Social Performance – PSP scale. These results suggest that cariprazine has the ability to improve not only the positive and negative symptoms, but the everyday functioning and social competence of patients, which in turn results in a better quality of life.

To improve quality of life, patients also need to be diagnosed and treated as early as possible. According to a post-hoc analysis, cariprazine was found to be effective in treating patients in the early stage of schizophrenia (first five years of the disorder). Importantly, this was observed not only in the overall symptomatology, but in the positive, negative and hostility-related symptoms, which are most characteristic in this period of the illness.

The biggest risk-factor for relapse for patients in the early course of the disorder is non-adherence. It is most common when side effects are unbearable or unacceptable for patients. Based on a post-hoc analysis comparing stable patients discontinuing cariprazine treatment versus patients taking cariprazine long term (in all stages of schizophrenia), it was shown that cariprazine is generally safe and well tolerated and relapse occurred less with cariprazine treatment than with placebo. Thus, the overall results suggest that adherence might be improved with cariprazine treatment.

About Cariprazine

Cariprazine, a potent dopamine D3/D2 receptor partial agonist with preferential binding to D3 receptors, is approved in the EU for the treatment of schizophrenia in adults under the brand name Reagila® and in the US for the treatment of schizophrenia and manic, mixed or depressive episodes associated with bipolar I disorder under the brand name Vraylar®. In addition, cariprazine is being investigated as an adjunctive treatment for major depressive disorder in adults. Cariprazine is protected by a composition-of-matter patent that expires in 2029. Cariprazine was discovered by Gedeon Richter Plc. and is licensed to Allergan (AbbVie) in America and to Recordati SpA in Western European Countries.

About Richter

Gedeon Richter Plc. (http://www.richter.hu), headquartered in Budapest/Hungary, is a major pharmaceutical company in Central Eastern Europe, with an expanding direct presence in Western Europe, in China and in Latin America. Having reached a market capitalization of EUR 3.6 billion (USD 4.1 billion) by the end of 2019, Richter's consolidated sales were approximately EUR 1.6 billion (USD 1.7 billion) during the same year. The product portfolio of Richter covers many important therapeutic areas, including women's healthcare, central nervous system and cardiovascular areas. Having the largest R&D unit in Central Eastern Europe, Richter's original research activity focuses on CNS disorders. With its widely acknowledged steroid chemistry expertise, Richter is a significant player in the women's healthcare field worldwide. Richter is also active in biosimilar product development.

About Recordati

Recordati, established in 1926, is an international pharmaceutical group, listed on the Italian Stock Exchange (Reuters RECI.MI, Bloomberg REC IM, ISIN IT 0003828271), with a total staff of more than 4,100, dedicated to the research, development, manufacturing and marketing of pharmaceuticals. Headquartered in Milan, Italy, Recordati has operations in the main European countries, in Russia, other Central and Eastern European countries, Turkey, North Africa, the United States of America, Canada, Mexico and in some South American countries. An efficient field force of medical representatives promotes a wide range of innovative pharmaceuticals, both proprietary and under license, in a number of therapeutic areas including a specialized business dedicated to treatments for rare diseases. Recordati is a partner of choice for new product licenses for its territories. Recordati is committed to the research and development of new specialties with a focus on treatments for rare diseases. Consolidated revenue for 2019 was € 1,481.8 million.