FDA Okays New Atypical for Schizophrenia, Bipolar Disorder

Caroline Cassels


September 17, 2015

The US Food and Drug Administration (FDA) has approved a new medication for the treatment of schizophrenia and bipolar disorder in adults.

The FDA's approval of cariprazine (Vraylar, Forest Laboratories, Inc), an oral, once-daily atypical antipsychotic, is based on results of three 6-week clinical trials involving 1754 participants. According to the FDA, in each of the trials, the drug was shown to reduce symptoms of schizophrenia compared with placebo.

Similarly, three 6-week trials involving 1037 participants showed that the drug reduced symptoms of bipolar disorder.

As with other drugs in its class, cariprazine comes with a boxed warning advising healthcare professionals about an increased risk for death in older patients with dementia-related psychosis.

The most common side effects reported by participants receiving cariprazine in the clinical trials for schizophrenia were extrapyramidal symptoms, such as tremor, slurred speech, and involuntary muscle movements.

The most common side effects reported by trial participants receiving cariprazine for bipolar disorder were extrapyramidal symptoms, akathisia, dyspepsia, vomiting, somnolence, and restlessness.

"Schizophrenia and bipolar disorder can be disabling and can greatly interfere with day-to-day activities," Mitchell Mathis, MD, director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, said in a statement.

"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," he added.


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