Gedeon Richter: The incidence of side effects decreased over time with cariprazine

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BUDAPEST, Hungary, Oct. 18, 2022 /PRNewswire/ -- Between the 15-18^th of October 2022, during the 35^th Annual Meeting of the European College of Neuropsychopharmacology (ECNP), new analyses of cariprazine studies were presented by Gedeon Richter Plc. In the poster presentations it was shown that the incidence of adverse drug reactions with cariprazine decreased over time, higher doses of cariprazine do not seem to increase rescue medication use nor extrapyramidal symptom-related side effects, and that both 1.5 mg and 3.0 mg of cariprazine is an effective dose for the treatment of general symptoms of bipolar depression. Issues regarding polypharmacy, and the special needs of women with schizophrenia were also highlighted in an industry-sponsored product theater and satellite symposium.

One of the poster presentations at ECNP authored by Professor Christoph U. Correll highlighted that the incidence of adverse drug reactions with cariprazine decreases over time. This result was based on the post-hoc analysis of a long-term clinical trial (NCT01412060). The authors found that compared to the first 8 weeks (run-in-phase) of the trial, less adverse reactions were seen in the next 12 weeks (stabilization phase) and next 72 weeks (double-blind phase) of the trial. In case of akathisia, one of the most common adverse reactions with cariprazine, the incidence changed from 18.6% (run-in phase) to 6.0% (stabilization phase) and then 5.0% (double-blind phase). Importantly, adverse events with cariprazine were associated with relatively low discontinuation rates.

Another scientific poster by Professor Elmars Rancans analyzing the results of an open-label, flexible-dose study conducted in Latvia showed that in a real-world setting, all doses of cariprazine (1.5 mg, 3.0 mg, 4.5 mg and 6.0 mg) are equally used. Furthermore, higher doses of cariprazine do not seem to increase neither rescue medication use nor extrapyramidal-related symptoms such as akathisia. Compared to previous treatment, patients with schizophrenia needed less rescue medications with cariprazine and experienced fewer side effects.

Finally, the third scientific poster by Professor Roger S. McIntyre, highlighted that both 1.5 mg and 3.0 mg of cariprazine are effective doses in treating the general symptoms of bipolar depression. The post-hoc analysis based on pooled data from three clinical trials also found that the 3.0 mg dose might be more beneficial for patients with more severe symptoms.

During the Product Theater session organized jointly by Gedeon Richter and Recordati, dr Sofia Pappa addressed key clinical questions about dosing, polypharmacy, and related side effects. For instance, the question of when is the ideal timing to switch from another antipsychotic to cariprazine was answered.

In the Industry-sponsored Satellite Symposium, also organized by the two pharma companies, the topic schizophrenia in women was addressed. The symposium focused on the most recent findings regarding antipsychotic use in female patients, the issue with contraception as well as the place of cariprazine in female schizophrenia treatment.