NDA Submitted for Cariprazine for Schizophrenia, Bipolar I Disorder
Forest Laboratories and Gedeon Richter Plc announced that Forest has submitted a New Drug Application (NDA) to the FDA for cariprazine, seeking approval for the treatment of both schizophrenia and manic or mixed episodes associated with Bipolar I Disorder. Cariprazine is a potent dopamine D3/D2 receptor partial agonist with preferential binding to D3 receptors.
The application for the treatment of schizophrenia includes results from three positive trials in >1,700 patients, two fixed dose studies with active controls and one fixed-flexible placebo-controlled dose study using the change from baseline in Positive and Negative Syndrome Scale (PANSS) total score as primary efficacy endpoint.
The application for the acute treatment of manic or mixed episodes associated with Bipolar I Disorder includes results from three positive placebo-controlled trials in >1,000 patients, two flexible dose studies and one fixed-flexible dose study using the change from baseline in the Young Mania Rating Scale (YMRS) total score as primary efficacy endpoint.
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