FDA approves Vraylar as an adjunctive treatment for major depressive disorder.- AbbVie + Gedeon Richter

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.

"Many living with major depressive disorder find that their ongoing antidepressant therapy doesn't offer meaningful relief from the symptoms they experience every day," said Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie. "Today's approval of Vraylar provides an important new treatment option to meet a critical unmet medical need. AbbVie is committed to driving progress and advancing solutions for patients living with complex neuropsychiatric conditions."

MDD is one of the most common mental disorders in the U.S.; approximately one in five adults will experience this disorder during their lifetime. In a large U.S. study of adults with MDD, approximately 50 percent still had depressive symptoms with their first antidepressant. If some symptoms of depression persist while on an antidepressant, adding a different type of medication, often referred to as an adjunctive treatment, to the existing regimen may help.

"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 III clinical trial investigator. "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."

Cariprazine is marketed as Vraylar in the U.S., and in addition to being approved as an adjunctive therapy to antidepressants for the treatment of MDD in adults, it is FDA-approved to treat adults with depressive, acute manic and mixed episodes associated with bipolar I disorder, as well as schizophrenia.

Cariprazine is co-developed by AbbVie and Gedeon Richter Plc. More than 8,000 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.