Allergan says FDA accepts sNDA for depression med

Allergan announced that the U.S. FDA has accepted for review the company’s supplemental New Drug Application for VRAYLAR, seeking to expand the indication to include the treatment of depressive episodes associated with bipolar I disorder 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 total score. Both cariprazine 1.5 mg and 3 mg demonstrated superiority to placebo in reducing depressive symptoms associated with bipolar I depression.

https://thefly.com/landingPageNews.php?id=2795645