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FDA Approves Option for Schizophrenia, Bipolar Treatment

by U.S. Medicine

October 11, 2015

JERSEY CITY, NJ – A new option for treating schizophrenia and bipolar disorder in adults has been approved by the Food and Drug Administration.

The drug Vraylar, cariprazine in capsule form, is manufactured by Forest Laboratories LLC of Jersey City, NJ, and distributed by Actavis Pharma Inc. of Parsippany, NJ.

“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. “It is important to have a variety of treatment options available to patients with mental illnesses so that treatment plans can be tailored to meet a patient’s individual needs.”

In each of three six-week clinical trials involving 1,754 participants, Vraylar was shown to reduce the symptoms of schizophrenia compared to placebo, according to the FDA. In addition, the drug’s effectiveness in treating bipolar disorder was shown in a trio of three-week clinical trials of 1,037 participants.

The FDA notes that Vraylar and all other FDA-approved drugs used to treat schizophrenia and bipolar disorder have a Boxed Warning alerting health care professionals about an increased risk of death associated with the use of these drugs in older people with dementia-related psychosis, adding that neither Vraylar nor any other drug in this class is approved to treat such patients.


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