Gedeon Richter: Cariprazine is well tolerated in the early stage of schizophrenia and has a positive effect on engagement compared to another antipsychotic

April 13, 2021 4:00 AM EDT

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BUDAPEST, Hungary, April 13, 2021 /PRNewswire/ -- Between the 10-13th  April 2021, during the 29th Annual Meeting of the European Psychiatric Association (EPA) – which was held virtually due to the COVID-19 pandemic situation – new analysis of cariprazine studies with patients experiencing acute or predominant negative symptoms (PNS) of schizophrenia was presented by Gedeon Richter Plc. According to the scientific posters, cariprazine significantly improved patient engagement in individuals suffering from PNS compared to risperidone, and the co-administration of cariprazine with other antipsychotic medications did not show an unexpected safety profile nor overlapping toxicities. It was also shown that cariprazine was well-tolerated in the early stage of the illness (first five years) and the discontinuation rates due to unbearable side effects were also low.

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Schizophrenia is a chronic psychiatric disorder comprising positive, negative, and affective symptoms, as well as cognitive impairment. Schizophrenia affects about 1% of the population; an estimated 5 million people struggle with this disorder in the EU. Negative symptoms of schizophrenia affect up to 60% of patients and have a significant impact on their daily functioning. Antipsychotics have been proven to be an effective treatment of positive symptoms, nonetheless the management of negative symptoms remains a considerable clinical challenge.

Based on evidence from a double-blind clinical trial, cariprazine has been proven to significantly improve engagement, defined as the patient's desire and capability to re-engage with life, in individuals with PNS compared to risperidone based on the post-hoc analysis of 11 items of the Positive and Negative Syndrome Scale (PANSS-11). The improvement (in favor of cariprazine) was statistically significant from week 14 onwards. In addition, greater change from baseline was showed in almost all investigated PANSS items compared to risperidone. The importance of these results – highlighted in one of our scientific posters – is that cariprazine can not only alleviate symptoms and improve everyday functioning of PNS patients, but also has a positive impact on their engagement with their life and treatment, which is undeniably one of the most important issues for patients and their caregivers too.

The tolerability and safety of antipsychotics is also an important question, especially when it comes to polypharmacy, the administration of two or more medications at the same time. Although recommendations favor antipsychotic monotherapy for schizophrenia, polypharmacy is common in everyday clinical practice. This especially true in the case of switching medications, where during the cross-titration phase, the patient receives two or even more drugs for a certain amount of time, hence increasing the chance of experiencing side effects. Based on the results of the post-hoc analysis of a randomized, double blind, parallel group, active controlled study in adult patients with PNS, the co-administration of cariprazine with other antipsychotic medications did not show an unexpected safety profile, nor overlapping toxicities. Given the fact that during the treatment of the disorder switching of medication is fairly common, this can be considered as a great advantage for cariprazine.

Early discontinuation of antipsychotic medication due to intolerable side effects is one of the most common causes of relapse. As each relapse significantly decreases the possibility of preferable long-term outcomes, relapse prevention represents an important clinical target in the early stage of schizophrenia. The third scientific poster of Gedeon Richter shown at EPA 2021 Virtual concentrated on this issue by analyzing and pooling 4 phase II/III double blind placebo-controlled trials post-hoc. According to the results, cariprazine was well tolerated in the early stage of schizophrenia, and discontinuation rates due to unbearable side effects were low. Relapse occurred in only a low percentage of patients. Weight gain and sexual problems, two of the most important side effects for patients in the early stage of schizophrenia, affected less than 2% of patients who took cariprazine.

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. (www.gedeonrichter.com), 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 3.8 billion (USD 4.5 billion) by the end of 2020, Richter's consolidated sales were approximately EUR 1.6 billion (USD 1.8 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 4,300, dedicated to the research, development, manufacturing and marketing of pharmaceuticals. Headquartered in Milan, Italy, Recordati has operations in Europe, Russia and the other C.I.S. countries, Ukraine, 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 several 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 2020 was € 1,448.9 million.

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SOURCE Gedeon Richter Plc.



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