The FDA has accepted a supplemental New Drug Application for Vraylar to treat bipolar depression.- Allergan
Allergan plc announced that the FDA has accepted for review the company's supplemental New Drug Application (sNDA) for Vraylar (cariprazine), seeking to expand the indication to include the treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults in the current product label.
The sNDA is supported by data from three pivotal trials, including RGH-MD-53, RGH-MD-54 and RGH-MD-56. In all three pivotal studies, cariprazine demonstrated greater improvement than placebo for the change from baseline to week 6 on the Montgomery Asberg Depression Rating scale (MADRS) total score. Both cariprazine 1.5 mg and 3 mg demonstrated superiority to placebo in reducing depressive symptoms associated with bipolar I depression.
Cariprazine was approved by the FDA in September 2015 and is marketed as Vraylar in the US for the treatment of schizophrenia in adults and acute treatment of manic or mixed episodes associated with bipolar I disorder in adults..
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