Vraylar Approved for Schizophrenia, Bipolar Disorder

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The FDA has approved cariprazine (Vraylar) to treat schizophrenia and manic or mixed episodes associated with bipolar disorder.

The FDA has approved cariprazine (Vraylar) to treat schizophrenia and manic or mixed episodes associated with bipolar disorder.

“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 a 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.”

Vraylar was shown to reduce schizophrenia symptoms better than placebo in 6-week trials involving a total of 1754 patients. It also reduced bipolar disorder symptoms in 3-week trials involving 1037 patients.

While Vraylar has not been approved to treat seniors with dementia-related psychosis, the drug does carry a Boxed Warning informing health care professionals that it may increase the risk of death in these patients.

Adverse effects for patients taking Vraylar for schizophrenia may include tremor, slurred speech, and involuntary muscle movements. Patients taking the treatment for bipolar disorder may experience akathisia, dyspepsia, vomiting, drowsiness, and restlessness, in addition to tremor, slurred speech, and involuntary muscle movements.

Vraylar is manufactured by Forest Laboratories LLC and distributed by Allergan and Gedeon Richter.

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