Cariprazine Significantly Improved Negative Symptoms of Schizophrenia Based on Real Life Data from a New Observational Study by Gedeon Richter Plc

BUDAPEST, Hungary, July 8, 2020 /PRNewswire/ -- On 4-7 July 2020, during the 28th Annual Meeting of the European Psychiatric Association (EPA) – which was held virtually due to the COVID-19 pandemic situation – new analysis of cariprazine studies in negative symptoms of schizophrenia was presented. An observational study conducted in outpatient psychiatric clinics provided real life data and proved that cariprazine significantly improved the negative symptom domain of schizophrenia in previously insufficiently treated patients, and that the safety profile of the medicine is favorable. It was also shown that cariprazine was generally comparable to placebo concerning cardiac parameters, with minimal observed changes in heart rate and QT interval. Based on posthoc analyses of cariprazine and risperidone it was also highlighted that only cariprazine improved negative symptoms in acute patients.

Schizophrenia is a chronic psychiatric disorder comprising positive, negative, and mood symptoms, as well as cognitive impairment. Schizophrenia affects about 1% of the population; 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. Antipsychotics have been proven effective in the treatment of positive symptoms, but treatment of schizophrenia with negative symptoms remains a huge clinical challenge.

Based on evidence from double-blind trials cariprazine has been proven across schizophrenia symptom domains, but real-life data, studies that measure effectiveness and impact in everyday practice are also essential. Gedeon Richter conducted a 16-week observational study conducted in 116 outpatients in Latvia. Based on the results: cariprazine significantly improved the negative symptom domain of schizophrenia based on clinical judgment, in patients with insufficient response who express predominantly negative symptoms. Pre-existing side effects gradually deceased in severity, and no weight changes were observed during treatment, indicating that cariprazine has a good safety profile. Importantly, the majority of doctors were highly satisfied with both the efficacy and tolerability profile of cariprazine.

Another four posters were also presented at the EPA 2020 conference:

1. Long-term treatments with antipsychotics are indicated for all patients with schizophrenia. Antipsychotic drugs can be of great benefit, but treatment might be associated with unpleasant side effects like cardiac complications. That is why a post hoc cardiac safety analysis was also conducted in relation to cariprazine treatment and presented at EPA. Based on the results concerning cardiac parameters, cariprazine was generally comparable to placebo. Changes in heart rate and QT interval were minimal and incidence of cardiac adverse events and discontinuation rates were fairly low.
   
2. A posthoc analysis about the efficacy of cariprazine vs. risperidone in the treatment of acute and primary negative symptoms of schizophrenia was also shown at EPA. While cariprazine and risperidone were equally effective in controlling acute overall symptoms, only cariprazine improved negative symptoms in acute patients. Cariprazine treatment was better than risperidone for predominantly negative symptoms of schizophrenia.
   
3. Gedeon Richter together with external experts performed two network analyses of symptoms of schizophrenia in order to map their latent structure. One of the analyses shows that in the case of patients with predominant negative symptoms the majority of the negative symptoms are completely isolated and are not correlated with the other PANSS symptoms.

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 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. (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 billion.