AbbVie Announces Results from Two Phase 3 Trials of Cariprazine (Vraylar) as an Adjunctive Treatment for Major Depressive Disorder

AbbVie Announces Results from Two Phase 3 Trials of Cariprazine (Vraylar) as an Adjunctive Treatment for Major Depressive Disorder

AbbVie announced results from two phase 3 studies assessing Vraylar (cariprazine) as an adjunctive treatment for major depressive disorder. In Study 3111-301-001, cariprazine met its primary endpoint demonstrating statistically significant change from baseline to week six in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score in patients with major depressive disorder. In Study 3111-302-001, cariprazine demonstrated numerical improvement in depressive symptoms from baseline to week six in MADRS total score compared with placebo but did not achieve statistical significance. Full results from studies 3111-301-001 and 3111-302-001 will be presented at a future medical meeting. Based on the positive results of studies 3111-301-001 and the previously reported RGH-MD-75, along with the totality of other data, AbbVie intends to submit a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration for the expanded use of cariprazine for the adjunctive treatment of MDD.

Study 3111-301-001 was a randomized, double-blind, placebo-controlled, multicenter trial with 759 patients. The study was conducted in the United States, Bulgaria, Estonia, Germany, H...

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