FDA approves cariprazine for treatment of schizophrenia

FDA has approved cariprazine (Vraylar, Allergan and Gedeon Richter Plc.) for the treatment of schizophrenia and bipolar I disorder in adults.

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Bipolar I disorder and schizophrenia are chronic and disabling mental health disorders. People with bipolar disorder experience unusually intense emotional states, called “mood episodes.” There are different types of bipolar disorder. Bipolar I disorder is defined by manic or mixed episodes that last at least seven days, or by manic symptoms that are so severe that the person needs immediate hospital care. Bipolar disorder affects approximately 3.6 million Americans.

Schizophrenia is a mental disorder that affects how a person thinks, feels and acts. A person with schizophrenia may have difficulty distinguishing between what is real and what is not. Schizophrenia is characterized by the presence of positive symptoms like delusions or hallucinations, as well as negative symptoms such as emotional unresponsiveness. Schizophrenia affects more than 2.6 million Americans.

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Vraylar is a once-daily, oral atypical antipsychotic approved for the acute treatment of adult patients with manic or mixed episodes associated with bipolar I disorder and for the treatment of schizophrenia in adults.

“While the mechanism of action of Vraylar is unknown, the interaction of cariprazine with dopaminergic and serotonergic receptors in the CNS may explain its activity. Cariprazine has high binding affinity and acts as a partial agonist at the dopamine D3 and D2 receptors. Notably, Vraylar’s is the only available atypical efficacy with higher affinity for the D3 receptor than the D2 receptor. Vraylar is also a partial agonist at serotonin 5-HT1A receptors and has antagonist activity at serotonin 5-HT2A receptors,” said Gary Sachs, MD, founding director of the Bipolar Clinic and Research Program at the Massachusetts General Hospital and associate professor of psychiatry at Harvard Medical School. “Vraylar may also offer advantages due to the comparatively long half-life of the drug [2 to 4 days] and its active metabolite [1 to 3 weeks]. Patients taking Vraylar might be less susceptible to adverse outcomes due to occasional partial adherence than those taking treatments with a short half-life.”

FDA's approval was based on 6 placebo-controlled clinical trials involving more than 2,700 adults in which Vraylar demonstrated robust efficacy without evidence of any worsening of the metabolic parameters that are of concern for several other compounds classified as atypical antipsychotics, according to Dr Sachs.

Some of the most common side effects associated with the use of Vraylar in bipolar disorder included extrapyramidal symptoms (EPS), dyspepsia, vomiting, and somnolence. As for Vraylar's use in treating schizophrenia, the most common side effects were EPS, including restlessness and tremors.

Vraylar is also being investigated for the treatment of bipolar depression and as adjunctive treatment for major depressive disorder in adults.

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