Hungarian drug company Gedeon Richter and US partner Forest Laboratories said on Wednesday that the preliminary top-line results of Phase III trials of a new antipsychotic agent Cariprazine (RGH-188) for the treatment of patients with acute mania associated with bipolar I disorder have been positive.
In terms of the Young Mania Rating Scale (YMRS), a primary endpoint for the testing, patients suffering from acute mania treated with Cariprazine showed significant improvement in symptoms compared to placebo-treated patients beginning already on the fourth day of treatment, the drug companies said.
Analysis of data will be completed over the coming weeks.
Clinical trials of Cariprazine for the treatment of schizophrenia and bipolar depression are ongoing, and use of the agent in the supplementary treatment of major depressive-disorder is also being examined.
“These exciting positive Phase III results in patients with bipolar mania demonstrate the potential of cariprazine as a novel antipsychotic agent,” said Marco Taglietti, MD., Senior Vice President of Research and Development and President, Forest Research Institute. “We will continue to investigate the therapeutic benefits of this novel dual acting D3/D2 compound across other CNS disorders as well.”
“These data together with those of the Phase II program prove that cariprazine provides a clinically meaningful improvement with good tolerability in patients with acute mania associated with bipolar I disorder. It also confirms, the D3/D2 partial agonist research concept elaborated by Richter’s researchers was a valuable and novel approach,” commented Richter Research Director Zsolt Szombathelyi.
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