Phase III Studies 3111-301-001 and 3111-302-001 of Vraylar show statistically significant change in major depressive disorder.- AbbVie

In Study 3111-301-001, cariprazine showed a statistically significant change from baseline to week six in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score compared with placebo. Patients treated with cariprazine at 1.5 mg/day achieved improved MADRS total score at week six compared to placebo (p-value=0.0050). Patients treated with cariprazine at 3.0 mg/day demonstrated improvement in MADRS total score at week six over placebo but did not meet statistical significance (p-value=0.0727). 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 meet its primary endpoint for either the 1.5 mg/day or 3.0 mg/day dose. The safety results of cariprazine in all three studies were consistent with its established safety profile across indications with no new safety signals identified.

In a previously published Phase II/III registration-enabling study, RGH-MD-75, patients treated with cariprazine flexible doses of 2.0–4.5 mg/day in addition to ongoing antidepressant therapy (ADT) met the primary endpoint and achieved improved MADRS total scores at week eight compared to placebo (p-value=0.0114). Based on the positive results of studies 3111-301-001 and RGH-MD-75, and the totality of data reported, AbbVie intends to submit a supplemental New Drug Application (sNDA) with the FDA for the expanded use of cariprazine for the adjunctive treatment of MDD.