Cariprazine FDA-Approved as Adjunctive Therapy to Antidepressants


Cariprazine is now FDA-approved as an adjunctive therapy to antidepressants.

FDA approved


The US Food and Drug Administration (FDA) has approved AbbVie’s cariprazine (Vraylar) as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults.1

“Many living with [MDD] find that their ongoing antidepressant therapy does not offer meaningful relief from the symptoms they experience every day,” said Thomas Hudson, MD, senior vice president of research and development and chief scientific officer at AbbVie. “Today’s approval of Vraylar provides an important new treatment option to meet a critical unmet medical need.”1

Cariprazine is also FDA-approved to treat adults with depressive, acute manic and mixed episodes associated with bipolar I disorder (1.5 or 3 mg/day), as well as schizophrenia (1.5 to 6 mg/day). More than 8000 patients worldwide have been treated with cariprazine across more than 20 clinical trials evaluating the efficacy and safety of cariprazine for a broad range of psychiatric disorders.

“Patients with inadequate response to standard antidepressant medication are often frustrated by the experience of trying multiple medicines and still suffering from unresolved symptoms. Instead of starting over with another standard antidepressant, Vraylar works with an existing treatment and can help build on the progress already made,” said Gary Sachs, MD, clinical vice president at Signant Health, associate clinical professor of psychiatry at Massachusetts General Hospital, and lead phase 3 clinical trial investigator. “For adults living with [MDD], because of inadequate improvement in response to standard antidepressants, Vraylar is an efficacious adjunctive treatment option with a well-characterized safety profile.”1

In the phase 3 study 3111-301-001, cariprazine + ADT showed a clinically and statistically significant change from baseline to week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score compared with placebo + ADT.2

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 participants treated with cariprazine at 2-4.5 mg/day (mean dose 2.6 mg) + ADT compared with placebo + ADT.3

“When we were in the early stages of development for cariprazine, we focused on designing a compound that covers a range of symptoms for mental health conditions and affects the dopamine D3 receptor,” said István Greiner, PhD, research and development director at Gedeon Richter. “While schizophrenia and bipolar manic and mixed episodes were the first indications in the US market, we are thrilled to see the full potential of cariprazine unlocked with approvals in bipolar I depression, and now, as an antidepressant adjunct in major depressive disorder.”1


1. U.S. FDA approves Vraylar® (cariprazine) as an adjunctive treatment for major depressive disorder. AbbVie. News release. December 16, 2022. Accessed December 19, 2022.

2. AbbVie presents positive data from phase 3 study of cariprazine (Vraylar®) for the adjunctive treatment of major depressive disorder at 2022 APA Annual Meeting. AbbVie. News release. May 23, 2022. Accessed December 19, 2022.

3. AbbVie's cariprazine (Vraylar®) met primary endpoint in phase 3 study as an adjunctive treatment for major depressive disorder. AbbVie. News release. October 29, 2021. Accessed December 19, 2022.

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