FDA Approves Vraylar for Major Depressive Disorder

The FDA has approved AbbVie’s Vraylar (cariprazine), an oral antipsychotic approved to treat schizophrenia and bipolar depression, for an additional indication: as an adjunctive therapy to antidepressants to treat adults with major depressive disorder.

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, AbbVie said in a news release.

Major depressive disorder is one of the most common mental disorders in the United States. About one in five adults will experience this disorder during their lifetime.

The wholesale acquisition cost for a 30-day supply of Vraylar is $1,312.07 as of January 2022.

Gary Sachs, M.D.

“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, M.D., clinical vice president at Signant Health, associate clinical professor of psychiatry at Massachusetts General Hospital, and lead phase 3 clinical trial investigator.

Vraylar is co-developed by AbbVie and Gedeon Richter.

FDA’s approval is based on a phase 3 study showing 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 Vraylar at 1.5 mg a day plus an antidepressant therapy compared with placebo plus an 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 Vraylar at 2 mg to 4.5 mg/day plus an antidepressant therapy compared with placebo plus an antidepressant therapy

Vraylar was generally well tolerated in six- and eight-week studies.