Mental Health Rx Gets Go-Ahead

Vraylar (cariprazine), from Allergan and Gedeon Richter, approved to treat bipolar disorder, schizophrenia

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) A newly approved medication could help some patients with serious mental health disorders.

The US Food and Drug Administration (FDA) today approved Vraylar (cariprazine) to treat schizophrenia and bipolar disorder. The oral, once-daily medication is marketed by Allergan and Gedeon Richter.

Bipolar disorder is a mental health condition marked by dramatic swings in mood and activity levels. Schizophrenia is a disorder in which patients often have hallucinations, delusions, and erratic speech and behavior. According to an Allergan press release, these disorders affect over 3.6 million and 2.6 million Americans, respectively.

“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 press release. “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 FDA approved Vraylar, an atypical antipsychotic drug, to treat these conditions based on data from six studies — three of which looked at bipolar disorder patients and three of which looked at schizophrenia patients. Altogether, these studies included over 2,700 patients.

Vraylar appeared to improve symptoms for both bipolar disorder and schizophrenia patients. Side effects reported by bipolar patients included agitation, vomiting, trouble with movement, indigestion and tiredness. For schizophrenia patients, Vraylar's side effects included agitation and trouble with movement.

Like other schizophrenia and bipolar disorder drugs, Vraylar carries a boxed warning. This warning indicates that elderly patients with psychosis tied to dementia have an increased risk of dying while taking this drug. Vraylar is not approved to treat these patients, the FDA noted.

Review Date: 
September 17, 2015
Last Updated:
September 18, 2015