FDA Approves Cariprazine for Major Depressive Disorder


Cariprazine (Vraylar; AbbVie, Gedeon Richter) is indicated as an adjunctive therapy to antidepressants for treating adult patients with major depressive disorder.

The FDA has approved cariprazine (Vraylar; AbbVie, Gedeon Richter) as an adjunctive therapy to antidepressants for treating adult patients with major depressive disorder (MDD). Cariprazine is administered at a starting dosage of 1.5 mg once daily, which can be increased to 3 mg once daily on day 15, depending on clinical response and tolerability. The maximum recommended dosage is 3 mg once daily.

Cariprazine is also approved to treat adults with depressive, acute manic, and mixed episodes associated with bipolar I disorder, as well as schizophrenia. The oral, once-daily atypical antipsychotic has been administered to more than 8000 patients worldwide across more than 20 clinical trials analyzing its efficacy and safety in various psychiatric disorders. The latest approval for cariprazine provides a new treatment option for adult patients who have shown a partial response to antidepressants.

"Many living with major depressive disorder find that their ongoing antidepressant therapy doesn't offer meaningful relief from the symptoms they experience every day," Thomas Hudson, MD, senior vice president, research and development, chief scientific officer, AbbVie, said in a press release. "[The] approval of Vraylar provides an important new treatment option to meet a critical unmet medical need."

When certain symptoms of depression persist despite treatment with an antidepressant, adding an adjunctive therapy to the patient’s existing regimen may improve these symptoms. MDD is among the most common mental health disorders in the United States, with approximately 1 in 5 adults experiencing the condition in their lifetime. A large study of adults with MDD found that approximately 50% had persistent depressive symptoms with their first antidepressant, according to an AbbVie press release.

In the phase 3 Study 3111-301-001, treatment with cariprazine produced a clinically and statistically significant change from baseline to week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score for those administered cariprazine at 1.5 mg/day plus ADT compared with placebo plus ADT. In the registration-enabling RGH-MD-75 study, cariprazine produced a clinically and statistically significant change from baseline to week 8 in the MADRS total score for patients administered cariprazine at 2-4.5 mg/day (mean dose 2.6 mg) plus ADT compared with placebo plus ADT.

"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," lead phase 3 clinical trial investigator Gary Sachs, MD, clinical vice president at Signant Health, associate clinical professor of psychiatry at Massachusetts General Hospital, said in a press release. "For adults living with major depressive disorder, because of inadequate improvement in response to standard antidepressants, Vraylar is an efficacious adjunctive treatment option with a well-characterized safety profile."

In clinical trials, dosage titration at intervals of fewer than 14 days was found to produce a higher incidence of adverse events (AEs). In 6- and 8-week studies, cariprazine was generally well tolerated.

The most common AEs observed in clinical studies for MDD ≥ 5% and at least twice the rate of placebo were akathisia, nausea, and insomnia at the recommended doses in 6-week, fixed-dose trials. In the 8-week, flexible-dose trial at a titration of less than 14 days, the most common AEs were akathisia, restlessness, fatigue, constipation, nausea, increased appetite, dizziness, insomnia, and extrapyramidal symptoms.

"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," István Greiner, PhD, research and development, director, Gedeon Richter, said in a press release. "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."


U.S. FDA Approves VRAYLAR® (cariprazine) as an Adjunctive Treatment for Major Depressive Disorder. AbbVie. News release. December 16, 2022.

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