In early 2025 AbbVie reported additional Phase 3 results (Study 3111-301-001) evaluating Vraylar as an adjunctive treatment in adults with major depressive disorder (MDD) who demonstrated inadequate response to SSRIs or SNRIs. In the pivotal trial, cariprazine 1.5 mg/day achieved a statistically significant reduction in MADRS (Montgomery–Åsberg Depression Rating Scale) total scores at Week 6 compared to placebo (p≈0.005). However, the higher 3 mg/day dose did not reach statistical significance. A complementary registrational study (RGH-MD-75) involving flexible dosing (2–4.5 mg/day) demonstrated a meaningful reduction in MADRS at Week 8. Safety outcomes were consistent with Vraylar’s established profile—akathisia, weight gain, and extrapyramidal symptoms were most common, with no new safety signals reported.

Citation: https://pharmaphorum.com/news/abbvie-adds-to-vraylar-data-as-fda-considers-depression-use

Implications: AbbVie’s sNDA filing—under FDA review with a decision expected by year-end 2025—positions Vraylar as a potential fourth indication in MDD adjunctive use. While efficacy appears modest and dose-dependent, Vraylar’s partial-agonist mechanism may appeal for patients with residual symptoms. Access may be limited by competition from generic aripiprazole, quetiapine, and the forthcoming generic Rexulti expected in 2026.