AbbVie's Phase III Vraylar data come up with mixed results in MDD

Shares of US pharma firm AbbVie (NYSE: ABBV) closed up 4.2% at $114.15 on Friday after it released top-line results from two Phase IIU clinical trials, Study 3111-301-001 and Study 3111-302-001, evaluating the efficacy and safety of cariprazine (marketed as Vraylar) as an adjunctive treatment for patients with major depressive disorder (MDD), but which saw mixed results.

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 1.5mg/day achieved improved MADRS total score at week six compared to placebo (p-value=0.0050). Patients treated with cariprazine at 3.0mg/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 1.5mg/day or 3.0mg/day dose.