AbbVie (NYSE:ABBV) has announced that the FDA has approved Vryalar (cariprazine) as an adjunctive therapy to antidepressants to treat major depressive disorder (MDD) in adults.
Cariprazine is a novel atypical antipsychotic drug (APD) that works as a partial agonist at the dopamine D2 and D3 receptors and serotonin 5-HT1A receptors. It works as an antagonist at the 5-HT2B serotonin receptors.
The indication is the fourth for the drug, which first scored FDA approval as an acute schizophrenia treatment and for bipolar disorder in 2015. Two years later, the drug won an indication as a maintenance treatment for schizophrenia. In 2019, cariprazine won expanded use to treat depressive episodes related to bipolar depression in adults.
Cariprazine is the only dopamine and serotonin partial agonist to win FDA approval for MDD and the depressive episodes associated with bipolar I disorder.
Supported by clinical data demonstrating efficacy and well-establis…