FDA has approved cariprazine (Vraylar) capsules, an atypical antipsychotic, indicated for the treatment of adults with schizophrenia as well as bipolar I disorder, based on controlled trials of more than 2,700 individuals.
Schizophrenia, a severe and disabling brain disorder, affects about one percent of the U.S. population. Approximately 9 out of 10 men with schizophrenia will manifest the disease by age 30, compared with only 2 out of 10 women. Individuals with schizophrenia are at increased risk for suicide, according to the Centers for Disease Control and Prevention (CDC).
Bipolar disorder, also known as manic depressive disorder, affects approximately 4 percent of individuals and typically presents at age 25, with a higher prevalence among women. The costs of treating this debilitating mental illness costs more than twice that of depression, the CDC noted.
“Schizophrenia and bipolar disorder can be disabling and can greatly interfere with day-to-day activities,” said Mitchell Mathis, MD, director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, in an FDA statement. “It is important to have a variety of treatment options available to patient with mental illnesses so that treatment plans can be tailored to meet a patient’s individual needs.”
Cariprazine, manufactured by Forest Laboratories and licensed to Actavis, now Allergan, was evaluated based on three 3-week clinical trials in adults with manic or mixed episodes of bipolar I disorder of more than 1,000 study participants. The drug was also evaluated based on three 6-week trials in adults with schizophrenia, with more than 1,700 participants. In all of the trials, cariprazine demonstrated efficacy in reducing the symptoms of bipolar disorder and schizophrenia compared with placebo.
During the trials, the most common side effects of schizophrenia patients receiving cariprazine were extrapyramidal symptoms and akathisia. Bipolar disorder patients who received cariprazine during the trials also experienced side effects, including extrapyramidal symptoms, akathisia, dyspepsia, vomiting, drowsiness, and restlessness.
Cariprazine carries a black box warning that it should not be used for the treatment of elderly patients with dementia-related psychosis because of the increased risk of mortality. This is the same warning carried by other drugs in this class. For more information, visit www.VRAYLAR.com/.