Similar Response Rate but Higher Degrees of Clinical Improvement Were More Likely to Achieve With Cariprazine Compared to Risperidone - A Study by Gedeon Richter Plc

BUDAPEST, Hungary, Sept. 11, 2019 /PRNewswire/ -- On 7-10 September 2019, during the 32th psychiatry congress of the European College of Neuropsychopharmacology Congress (ECNP) in Copenhagen new analysis of cariprazine studies were presented. According to the presentation, clinical improvement of patients with predominant negative symptoms was significantly better with cariprazine, compared with risperidone treatment, the distribution of clinical improvement categories was significantly different between the two treatment groups in favor of cariprazine.

It was also demonstrated that there is a strong correlation between improvement of negative symptoms - measured by PANSS Factor Score for Negative Symptoms (PANSS-FSNS) - and improvement of functionality - measured by the Personal and Social Performance Scale.

Akathisia- one of the common side effects of antipsychotic treatment- profile of cariprazine was also shown: in most cases symptoms were mild to moderate and were manageable.

The chronic brain disorder schizophrenia is comprising positive, negative, and mood symptoms, as well as cognitive impairment and affects about 1% of the population: potentially an estimated 5 million people struggle with this illness in the EU. Negative symptoms of schizophrenia affect up to 60% of patients depending on the reference used and have a significant impact on their daily function. That means that within the EU up to 3 million people can be suffering from these symptoms.

Antipsychotics are effective in the treatment of positive symptoms, but treatment of schizophrenia with negative symptoms remains a huge clinical challenge. According to the results of different post hoc analyses and clinical researches, cariprazine seems to be an adequate answer to these challenges.

Based on an international, 26-week, randomized, double-blind, active-controlled fixed-flexible-dose trial in adults with negative symptoms of schizophrenia while clinical response rates as measured by the CGI-I were similar in the two treatment groups (cariprazine and risperidone), higher degrees of clinical improvement were more likely to be achieved with cariprazine. Much and very much improvement was achieved by more cariprazine-treated patients, while categories with less improvement were more likely in the risperidone group. What's more, the maximal clinical improvement was reached by significantly more patients in the cariprazine group.

As for the safety profile of cariprazine, based on eight schizophrenia clinical studies (with 2.048 patients in the CAR and 683 patients in the PBO group) cariprazine was generally safe and well tolerated. The most frequent adverse events were akathisia and EPS, which were mostly mild to moderate in intensity and rarely led to study discontinuation. Regarding akathisia, in the approved dose range of cariprazine (1.5-6mg), the incidence of this adverse effect was 14.6%. In most cases, symptoms were mild to moderate in intensity (>95%), were not associated with an increased risk of suicidality, and they were well managable with anti-EPS treatment or down-titration.

Data from a randomized 26 week-long double-blind treatment shows that the improvement of different set of predominant negative symptoms were significantly associated with the improvement of personal and social performance. Based on the presented regression analysis, the improvement of predominant negative symptoms was significantly associated with the improvement of personal and social performance. Socially useful activities, personal and social relationships and self-care were associated with the improvement of a different set of negative symptoms, of which passive social withdrawal seemed to be the most influencing.

All in all, the analyses presented at the conference, underlined that cariprazine can be a reliable and effective treatment possibility for patients with predominant negative symptoms, it is significantly improving patient functioning and that if akathisia occurs what steps can be taken.

Cariprazine is marketed under the brand name Vraylar in the US for the treatment of schizophrenia and manic, mixed or depressive episodes associated with bipolar I disorder. In the EU it was licensed for schizophrenia in 2017 by EMA under the brand name Reagila and already marketed in 19 European countries; in Eastern Europe by Richter and in Western Europe by Recordati. Subsequent European launches are expected during the course of 2019 and 2020.

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 in late-stage clinical studies as adjunctive treatment for major depressive disorder in adults. Cariprazine is protected by a composition-of-matter patent that expires in 2029 in most of the major markets. Cariprazine was discovered by Gedeon Richter Plc. and is licensed to Allergan in America and to Recordati SpA in Western European Countries.

About Richter

Gedeon Richter Plc. ( 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 3.2 billion (USD 3.6 billion) by the end of 2018, Richter's consolidated sales were approximately EUR 1.4 billion (USD 1.6 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 throughout the whole of Europe, including Russia, Turkey, North Africa, the United States of America, Canada, Mexico, some South American countries, Japan and Australia. 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 2018 was EUR 1,352.2 million, operating income was EUR 442.2 million and net income was EUR 312.4 million.

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SOURCE Gedeon Richter Plc.