Allergan and Gedeon Richter announced that the Food and Drug Administration (FDA) has approved Vraylar (cariprazine) capsules for the treatment of manic or mixed episodes associated with bipolar I disorder and for the treatment of schizophrenia in adults. 

The FDA’s approval was based on data from three 3-week controlled trials in adults with manic or mixed episodes of bipolar I disorder and three 6-week placebo-controlled trials in adults with schizophrenia, which included over 2,700 adults total. Treatment with Vraylar showed improvement vs. placebo as measured by Young Mania Rating Scale (YMRS) total scores in patients with bipolar mania and by Positive and Negative Syndrome Scale (PANSS) total scores in patients with schizophrenia. Vraylar also showed efficacy as measured by the Clinical Global Impressions-Severity (CGI-S) rating scale, meeting the study’s secondary efficacy endpoints for both conditions. 

RELATED: FDA Wants More Data for Cariprazine in Psychosis Disorders 

Vraylar is an atypical antipsychotic that exerts its effect through a combination of partial agonist activity at central dopamine D2 and serotonin 5-HT1A receptors and antagonist activity at serotonin 5-HT2A receptors. It acts as an antagonist at 5-HT2B and 5-HT2A receptors with high and moderate binding affinity as well as it binds to the histamine H1 receptors. Cariprazine shows lower binding affinity to the serotonin 5-HT2C and alpha1A– adrenergic receptors and has no appreciable affinity for cholinergic muscarinic receptors.

Vraylar will be available as 1.5mg strength capsules in a 7-count blister pack and 30- and 90-count bottles; and as 3mg, 4.5mg, and 6mg strength capsules in 30- and 90-count bottles. 

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