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AbbVie submits sNDA for Vraylar as an add-on treatment for MDD

February 22, 2022

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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 presentation of Vraylar (cariprazine, AbbVie) on previously announced clinical trial results.

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 drug-treated patients at 1, 5 mg per day versus placebo, according to the release. A registration study demonstrated a clinically and statistically significant change from baseline to 8 weeks in the MADRS total score for people treated with cariprazine 2 mg to 4.5 mg daily compared to placebo.

Both studies reported safety data consistent with the established safety profile of cariprazine for all indications. The researchers did not report any new security-related events.

Additional results supporting the submission come 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 treatment that reduces their depressive symptoms, and many take years to find the right treatment,” Michael Severino, MD, vice president and president of AbbVie, said in the statement. “Cariprazine, when added to ongoing antidepressant treatment in patients with major depressive disorder, has been shown to reduce depressive symptoms. We look forward to working closely with the FDA as we review our submission to bring potential new adjunct therapy to patients with major depressive disorder who are taking an antidepressant and seeking additional relief.