Cariprazine Approved by FDA as Adjunctive Treatment for Major Depressive Disorder
AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved VRAYLAR® (cariprazine) ; (known as Reagila in Australia) as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults.
Cariprazine is not approved for MDD in Australia.
Cariprazine, is a D2/D3 partial agonist with the D3 partial agonism being a unique mechanism of action.
Cariprazine is evidence based in the treatment of negative symptoms of schizophrenia.
With the FDA approval for use as an adjunct in MDD, this groundbreaking approval marks a significant milestone in the field of mental health, as cariprazine is the first antipsychotic drug to be approved for this indication in the United States.
This approval is an important step forward in providing effective treatment options for individuals with MDD and will likely lead to improved outcomes in treatment resistant depression.
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.
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 negative symptoms of schizophrenia.
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