AbbVie's Antipsychotic Drug Scores FDA Approval As Adjunct Therapy For Depression Patients

The FDA approved AbbVie Inc's ABBV Vraylar (cariprazine) as an adjunctive therapy to antidepressants for major depressive disorder (MDD) in adults.
Supported by clinical data demonstrating efficacy and well-established tolerability, this additional indication provides a new option for adults who have a partial response to the treatment of an antidepressant.
In addition to being approved as an adjunctive therapy to antidepressants for MDD in adults, it is FDA-approved to treat adults with depressive, acute manic, and mixed episodes associated with bipolar I disorder and schizophrenia.
Cariprazine is co-developed by AbbVie and Gedeon Richter Plc.
A Phase 3 Study 3111-301-001 showed a clinically and statistically significant change from baseline to week six in the depression score for patients treated with cariprazine at 1.5 mg/day + antidepressant monotherapy (ADT) compared with placebo + ADT.
A second registration-enabling study, RGH-MD-75, showed a clinically and statistically significant change from baseline to week eight in the depression score for patients treated with cariprazine at 2-4.5 mg/day (mean dose 2.6 mg) + ADT compared with placebo + ADT.
Price Action: ABBV shares closed lower by 1.61% at $160.48 on Friday.
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