Supplemental New Drug Application submitted to FDA for Vraylar for the adjunctive treatment of major depressive disorder – AbbVie

AbbVie announced that it has submitted a supplemental New Drug Application (sNDA) for cariprazine (Vraylar) to the FDA for the adjunctive treatment of major depressive disorder (MDD) in patients who are receiving ongoing antidepressant therapy. The submission is supported by results from previously announced clinical trials.

A Phase III Study 3111-301-001 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. A second registration-enabling study, RGH-MD-75, showed a clinically and statistically significant change from baseline to week eight in the MADRS total score 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 established safety profile of cariprazine across indications, with no new safety events identified. Also supporting the submission is study RGH-MD-76 that examined the long-term safety and tolerability of cariprazine over 26 weeks.

“Many people living with major depressive disorder struggle to find a treatment that reduces their depressive symptoms, with many taking years to find the right treatment. Cariprazine, when added to ongoing antidepressant treatment in patients with major depressive disorder, demonstrated that it can reduce depressive symptoms,” said Michael Severino, M.D., vice chairman and president, AbbVie. “We look forward to working closely with the FDA during the review of our submission to bring a potential new adjunctive therapy to patients with major depressive disorder who are taking an antidepressant and seeking additional relief. This submission demonstrates our strong commitment to addressing additional gaps in the care of people affected by psychiatric disorders.”

Cariprazine is marketed as Vrayler in the United States and is FDA-approved to treat adults with depressive, acute manic and mixed episodes associated with bipolar I disorder, as well as schizophrenia. Cariprazine is being co-developed by AbbVie and Gedeon Richter Plc. More than 8,000 patients worldwide have been treated with cariprazine across more than 20 clinical trials evaluating the efficacy and safety of cariprazine for a broad range of psychiatric disorders.