New Drug Application Submitted for Cariprazine in the Treatment of Major Depressive Disorder

AbbVie has submitted a new drug application (NDA) for cariprazine (VRAYLAR®) to the US Food and Drug Administration (FDA) for the adjunctive treatment of major depressive disorder (MDD) in patients who are receiving ongoing antidepressant therapy.

"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, MD, vice chairman and president, AbbVie, in a press release. 

If cariprazine is approved, it will be the fourth indication for cariprazine, which currently includes the following: treatment of adults with schizophrenia; the acute treatment of manic or mixed episodes associated with bipolar I disorder; and the treatment of depressive episodes associated with bipolar I disorder.

The NDA is supported by a double-blind, placebo-controlled, multicenter, phase 3 study that displayed clinically and statistically significant change from baseline to week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score for patients treated with cariprazine at 1.5 mg/day compared with placebo. Additionally, a second registration-enabling study “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” over 26 weeks.

Both studies did not identify new safety events safety data were consistent with the established safety profile of cariprazine across indications.

"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," Dr Severino added.

Reference

AbbVie submits supplemental new drug application to US FDA for cariprazine (VRAYLAR) for the adjunctive treatment of major depressive disorder. News release. Cision PR Newswire. February 22, 2022. Accessed February 23, 2022.