FDA Approves Cariprazine as an Adjunctive Treatment for Major Depressive Disorder
January 11, 2023   

The U.S. Food and Drug Administration (FDA) has approved cariprazine (VRAYLAR, AbbVie) as an adjunctive therapy to antidepressants for the treatment of 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.

The approval comes from data from the Phase II Study 3111-301-001 which showed a clinically and statistically significant change from baseline to week six in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score for patients treated with cariprazine at 1.5 mg/day + antidepressant therapy compared with placebo + antidepressant therapy. A second registration-enabling study, RGH-MD-75, showed a clinically and statistically significant change from baseline to week eight in the MADRS total score for patients treated with cariprazine at 2-4.5 mg/day (mean dose 2.6 mg) + antidepressant therapy compared with placebo + antidepressant therapy.

Cariprazine showed to be generally well tolerated in 6- and 8-week studies. The starting dosage of cariprazine is 1.5 mg once daily. Depending upon clinical response and tolerability, the dosage can be increased to 3 mg once daily on Day 15. In clinical trials, dosage titration at intervals of less than 14 days resulted in a higher incidence of adverse reactions. The maximum recommended dosage is 3 mg once daily. Most common adverse reactions observed in the adjunctive MDD studies (= 5% and at least twice the rate of placebo) were akathisia, nausea, and insomnia at the recommended doses in 6-week, fixed-dose trials.

>>  AbbVie Press Release

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