Allergan has announce the availability of Vraylar (cariprazine capsules) for the acute treatment of manic or mixed episodes associated with bipolar 1 disorder and for the treatment of schizophrenia 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.
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.
Cariprazine is also being investigated for the treatment of bipolar depression, the negative symptoms of schizophrenia, and as adjunctive treatment for major depressive disorder in adults.
In schizophrenia patients, the most common adverse reactions reported include extrapyramidal symptoms and akathisia; in bipolar mania patients, adverse reactions also included dyspepsia, vomiting, somnolence, and restlessness. Because plasma levels of cariprazine and its major metabolites accumulate over time, adverse reactions may first appear several weeks after initiating Vraylar and monitoring for these events should continue for several weeks after starting the drug and after each dosage increase. Vraylar carries a boxed warning that states the drug is not approved for patients with dementia-related psychosis and that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
Vraylar will be commercially available in 30-count bottles in 1.5mg, 3mg, 4.5mg and 6mg strengths and a 7-count mixed blister pack (one 1.5mg and six 3mg capsules).
For more information visit Vraylar.com.