AbbVie submits sNDA for Vraylar as adjunctive MDD treatment

AbbVie has submitted a supplemental new drug application for Vraylar to the FDA for the adjunctive treatment of major depressive disorder in patients receiving ongoing antidepressant therapy, according to a press release.

The company based the submission of Vraylar (cariprazine, AbbVie) on results from previously announced clinical trials.

A phase 3 study showed a clinically and statistically significant change from baseline to 6 weeks in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score for patients treated with the drug at 1.5 mg per day vs. placebo, according to the release. A registration-enabling study demonstrated a clinically and statistically significant change from baseline to 8 weeks in the MADRS total score for those treated with cariprazine 2 mg to 4.5 mg per day vs. placebo.

Both studies reported safety data consistent with the established safety profile of cariprazine across indications. Researchers reported no new safety events.

Additional results supporting the submission came from a study that assessed 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,” Michael Severino, MD, vice chairman and president of AbbVie, said in the release. “Cariprazine, when added to ongoing antidepressant treatment in patients with major depressive disorder, demonstrated that it can reduce depressive symptoms. 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.”