Allergan PLC and Gedeon Richter PLC believe they now have adequate evidence for their atypical antipsychotic drug Vraylar (cariprazine) in the treatment of bipolar I depression to file an sNDA with the FDA in the second half of this year. Vraylar is currently approved for the treatment of schizophrenia in adults and the acute treatment of manic or mixed episodes associated with bipolar I disorder.
The duo said it could now press ahead with the new cariprazine filing armed with positive top-line evidence from three pivotal placebo-controlled studies in bipolar I depression, RGH-MD-53, RGH-MD-54 and...