Forest Laboratories and Gedeon Richter have announced the positive results of Phase III clinical trial of cariprazine (RGH-188).
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Cariprazine is an antipsychotic agent used to treat acute mania associated with bipolar I disorder.
This Phase III, multicenter, double-blind, placebo- controlled, parallel-group study evaluated the efficacy, safety, and tolerability of cariprazine monotherapy in patients with acute mania.
The study demonstrated that cariprazine-treated patients experienced significant symptom improvement compared to placebo-treated patients.
Th drug candidate is also being evaluated in clinical studies for patients with schizophrenia, bipolar depression, and as an adjunct treatment in MDD.
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