After reporting a few days ago that the drug proved effective, the information released by Richter today, on the website of the Budapest Stock Exchange, included more details about the safety of the drug, as proven in “phase IIIb” trials involving 461 patients.
“No treatment emergent adverse event was reported in more than 10% of the patients. The most frequent adverse events (incidence ≥5%) across both treatments groups were insomnia, headache, akathisia, worsening of schizophrenia symptoms, anxiety and somnolence,” the announcement said.
“We are very pleased about these positive phase III results. The preliminary data clearly demonstrates that in addition to the already shown efficacy in patients with schizophrenia and acute mania associated with bipolar I disorder, cariprazine has also the potential to become a novel promising therapeutic option for the unmet medical need of patients suffering from predominant negative symptoms of schizophrenia,” Richter’s research director Dr István Greiner said in the announcement posted on the website of the Budapest Stock Exchange. Greiner added that data from the trial will be further analyzed in the coming weeks.
The U.S. Food and Drug Administration (FDA) acknowledged the receipt of the two companies’ new drug application resubmission for cariprazine, according to an announcement earlier this month.
One of the blue chips on the Budapest Stock Exchange, Gedeon Richter has been concerned about reduced profits due to the economic troubles in Russia, where the firm has been earning nearly one quarter of its revenue.
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