AbbVie Seeks Vraylar OK for Major Depression

AbbVie has submitted a supplemental NDA for Vraylar (cariprazine) for the adjunctive treatment of major depressive disorder in patients who are receiving ongoing antidepressant therapy. The submission is based on data from a Phase 3 study that showed a clinically and statistically significant change from baseline to week six in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score for patients treated with cariprazine at 1.5 mg/day compared with placebo, according to the company. A separate study showed similar MADRS total score improvement for patients treated with cariprazine at 2-4.5 mg/day compared with placebo. In both of these studies, safety data were consistent with the drug’s established safety profile, it says. Cariprazine is currently approved for treating adults with depressive, acute manic and mixed episodes associated with Bipolar I disorder, as well as schizophrenia.