AbbVie Seeks FDA Approval for Cariprazine for Adjunctive Treatment of Major Depressive Disorder

In a phase 3 study, there were clinically and statistically significant changes observed 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 versus the placebo.

AbbVie has submitted a supplemental New Drug Application (sNDA) for cariprazine (Vraylar, AbbVie) to the FDA for the adjunctive treatment of major depressive disorder (MDD) in patients who are receiving ongoing antidepressant therapy.

Cariprazine is an oral, once-daily atypical antipsychotic indicated for the treatment of adults with manic or mixed episodes associated with bipolar 1 disorder (3 to 6 mg/day) and for the treatment of depressive episodes associated with bipolar 1 disorder in adults (1.5 or 3 mg/day). It has also been approved for the treatment of schizophrenia in adults (1.5 to 6 mg/day).

In a phase 3 study, there were clinically and statistically significant changes observed 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 versus the placebo.

In the second registration-enabling study, RGH-MD-75, there was a significant change from baseline to week 8 in the MADRS total score for patients treated with cariprazine at 2 to 4.5 mg/day compared with placebo. Both studies had consistent safety data with the established safety profile of cariprazine across indications, with no new safety events identified. Further, the study RGH-MD-76 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, MD, vice chairman and president, AbbVie, in a press release. "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 currently FDA-approved to treat adults with depressive, acute manic and mixed episodes associated with bipolar 1 disorder, and schizophrenia.

REFERENCE

AbbVie Submits Supplemental New Drug Application to U.S. FDA for cariprazine (VRAYLAR®) for the Adjunctive Treatment of Major Depressive Disorder. AbbVie. February 22, 2022. Accessed February 22, 2022. https://news.abbvie.com/news/press-releases/abbvie-submits-supplemental-new-drug-application-to-us-fda-for-cariprazine-vraylar-for-adjunctive-treatment-major-depressive-disorder.htm