AbbVie Reports Real-World Data For VRAYLAR In Depressive Disorder
(RTTNews) - AbbVie Inc. (ABBV) on Friday announced that it presented new real-world data on VRAYLAR at Psych Congress 2026 in New Orleans, highlighting its use in adults with major depressive disorder and bipolar I depression.
VRAYLAR (cariprazine) is an oral atypical antipsychotic approved for the treatment of schizophrenia and manic or mixed episodes associated with bipolar I depression (BP-I) in adults. It is also approved as an adjunctive treatment to antidepressants for major depressive disorder (MDD) in adults and for depressive episodes associated with BP-I disorder.
In the prospective, observational CreW BP-I study, 118 adults with BP-I depression were treated with VRAYLAR, with efficacy analyzed in 99 patients. After 12 weeks, mean Montgomery-Åsberg Depression Rating Scale (MADRS) scores fell from 32.2 at baseline to 19.9.
While Functional Assessment Short Test (FAST) scores declined from 43.3 to 30.7. Quality-of-life and other exploratory measures also improved. Nausea and dizziness were the most common treatment-emergent adverse events, each reported in 5.1-percentage of patients.
Interim results from the ProACt real-world study of adjunctive VRAYLAR in MDD showed mean PHQ-9 scores decreased from 15.7 at baseline to 7.1 at week 6, while FAST scores declined from 37.4 to 19.9. Improvements were also reported in anhedonia, motivation and energy.
Additionally, AbbVie also presented an indirect comparison of cariprazine and lumateperone in adjunctive MDD treatment, long-term pediatric safety data and a survey examining treatment preferences following inadequate antidepressant response.
Mudra Kapoor, Vice President, Global Medical Affairs of AbbVie, said, "The prospective studies provide further evidence of VRAYLAR's potential to improve depressive symptoms, functioning and patient-centered outcomes in routine clinical practice."
ABBV is trading down 0.06% at $263.87.
