New sNDA Submitted to FDA for Major Depressive Disorder

If approved, this will be the fourth indication for the drug, joining its approvals for episodes associated with bipolar I disorder and schizophrenia.

AbbVie has submitted a supplemental New Drug Application (sNDA) to the United States Food and Drug Administration (FDA) for cariprazine (Vraylar) for the adjunctive treatment of major depressive disorder (MDD) in patients engaged in ongoing antidepressant therapy.

This submission follows clinical trial results demonstrating clinical and statistically significant improvement in patients with MDD who were treated with cariprazine and an antidepressant. Using the Montgomery-Åsberg Depression Rating Scale (MADRS), 2 phase 3 studies—3111-301-001 and RGH-MD-75—showed improvement in patients treated with cariprazine at 1.5mg/day compared with placebo from baseline to week 6, and in patients treated with cariprazine at 2-4.5mg/day compared with placebo from baseline to week 8, respectively. Both studies were consistent with cariprazine’s established safety profile across indications. Another study supporting the sNDA submission was RGH-MD-76, which examined the long-term tolerability and safety of cariprazine over 26 weeks.1

“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,” said Michael Severino, MD, AbbVie vice chairman and president, in a press release. “Cariprazine, when added to ongoing antidepressant treatment in patients with major depressive disorder, demonstrated that it can reduce depressive symptoms.”

Cariprazine is already FDA-approved for the treatment of adults with depressive, acute manic, and mixed episodes related to bipolar I disorder and schizophrenia. Its efficacy and safety in the treatment of multiple psychiatric disorders has been evaluated in more than 8000 patients in over 20 clinical trials worldwide. If approved for the adjunctive treatment of MDD in patients receiving ongoing antidepressant therapy, cariprazine may help reduce depressive symptoms associated with MDD, which is one of the most common psychiatric disorders in the United States, with around 21 million adults experiencing at least 1 major depressive episode in 2020 alone.1

“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,” Severino said in a press release. “This submission demonstrates our strong commitment to addressing additional gaps in the care of people affected by psychiatric disorders.”

Reference

1. AbbVie submits supplemental New Drug Application to U.S. FDA for cariprazine (VRAYLAR®) for the adjunctive treatment of major depressive disorder. AbbVie. News Release. February 22, 2022. Accessed February 22, 2022.