Cariprazine is already approved to treat schizophrenia and bipolar I in adults.
AbbVie has submitted a supplemental New Drug Application to the FDA for cariprazine (Vraylar) for the adjunctive treatment of major depressive disorder (MDD) in patients receiving ongoing therapy with antidepressants.1
Results of a phase 3 study demonstrated a clinically and statistically significant change over a 6-week period in Montgomery-Åsberg Depression Rating Scale (MADRS) total score for patients who received 1.5 mg cariprazine per day compared with the placebo group. Results of a second registration-enabling study also demonstrated a clinically and statistically significant change from baseline to week 8. Safety data in each of these studies were consistent with the established cariprazine safety profile across treatment indications.
“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…demonstrated that it can reduce depressive symptoms,” said Michael Severino, MD, AbbVie vice chairman and president, in a news release.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 [MDD] who are taking an antidepressant and seeking additional relief.”