FDA approves new drug to treat schizophrenia, bipolar disorder

The U.S. Food and Drug Administration (FDA) recently approved Vraylar (cariprazine) capsules to be used for the treatment of schizophrenia and bipolar disorder in adults.

As a chronic, severe and disabling brain disorder that affects approximately 1 percent of Americans,  schizophrenia has seen an uptick in research to create drugs to control it. 

Symptoms are typically first seen in adults younger than 30, and include hearing voices or seeing things that are not there, believing other people are reading their minds or controlling their thoughts. That leads many suffering from the disorder to become suspicious or withdrawn.

Bipolar disorder, also known as manic-depressive illness, is another brain disorder that causes unusual shifts in mood, energy, activity levels and the ability to carry out day-to-day tasks.

“Schizophrenia and bipolar disorder can be disabling and can greatly interfere with day-to-day activities,” Dr. Mitchell Mathis, director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, said. “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.”

The efficacy of Vraylar in treating schizophrenia was demonstrated in 1,754 participants in three six-week clinical trials. Each trial showed Vraylar reduced the symptoms of schizophrenia compared to a placebo.

Vraylar’s ability to treat bipolar disorder was shown in three three-week clinical trials of 1,037 participants. Vraylar was shown to reduce symptoms of bipolar disorder in each of the trials.

Vraylar is manufactured by Forest Laboratories LLC of Jersey City, New Jersey. The newly approved drug is distributed by Actavis Pharma, Inc.