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news.Forest Laboratories and Gedeon Richter have reported positive results from Phase III trial of cariprazine (RGH-188), an investigational antipsychotic agent, in patients with acute mania associated with bipolar I disorder.
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The trial data showed that cariprazine treated patients with acute manic episodes experienced significant improvements in symptoms compared to placebo-treated patients.
The results of this study were consistent with the results observed in the two previously completed pivotal placebo-controlled cariprazine studies in this patient population, the company said.
Cariprazine is also currently being investigated in clinical studies for patients with schizophrenia, bipolar depression, and as an adjunct treatment for Major Depressive Disorder.
Gedeon research director Zsolt Szombathelyi said in the three consecutive positive trials, statistically significant results demonstrated improvement in symptoms compared to placebo, importantly including the low dose range arm.