Forest Laboratories, Inc. (FRX: Quote) and Gedeon Richter Plc announced positive top-line results in 2 Phase III clinical trials of cariprazine (RGH-188) for treating acute exacerbation of schizophrenia.
For the primary endpoint in each study, the Positive And Negative Syndrome Scale, the data showed that cariprazine-treated patients experienced significant symptom improvement compared to placebo-treated patients.
Besides, all doses showed statistically significant separation from placebo starting at week 2 and at each subsequent time point with the higher dose showing separation as early as week 1 of treatment. Further analyses of the data in each study will be completed in the coming weeks.
Forest Labs noted that the results of these 2 studies were consistent with the results of the previously completed placebo-controlled Phase IIb fixed-dose study in this population.
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by RTT Staff Writer
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