The Food and Drug Administration has approved Vraylar (cariprazine; Allergan) for the maintenance treatment of adults with schizophrenia.
The approval was based on a multinational, double-blind, placebo-controlled study in 200 adult patients with schizophrenia. Patients received either 3, 6 or 9mg per day of Vraylar or placebo for up to 72 weeks or until a relapse occurred.
Results showed that Vraylar significantly delayed the time to relapse compared to placebo (P=0.0010). A total of 49.5% (n=49/99) of placebo treated patients relapsed vs. 29.7% (n=30/101) of the Vraylar-treated patients. The safety results were consistent to previous studies.
Vraylar is already approved for the acute treatment of schizophrenia and the acute treatment of manic or mixed episodes of bipolar I disorder in adults.
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.
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