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FDA Approves New Drug for Schizophrenia Bipolar Disorder

Vraylar is an atypical antipsychotic taken once a day

FRIDAY, Sept. 18, 2015 (HealthDay News) -- A new antipsychotic drug to treat schizophrenia and bipolar disorder in adults has been approved by the U.S. Food and Drug Administration. The drug, Vraylar (cariprazine), is a capsule taken once a day.

The drug's effectiveness in treating schizophrenia was tested in 1,754 patients in three six-week clinical trials. It was shown to reduce schizophrenia symptoms compared to a placebo. The most commonly reported side effects in the schizophrenia trials were tremor, slurred speech, and involuntary muscle movements.

In three three-week trials involving 1,037 bipolar patients, Vraylar reduced disorder symptoms, the FDA said. The most common drug-related side effects in the bipolar disorder trials included tremor, slurred speech, akathisia, dyspepsia, vomiting, drowsiness, and restlessness.

All FDA-approved drugs for schizophrenia and bipolar disorder must carry a black-box warning indicating an increased risk of death if these drugs are used by older people with dementia-related psychosis, the agency noted.

The drug's maker, Forest Labs, and distributor, Actavis Pharma, are based in New Jersey.

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