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FDA Approves Atypical Antipsychotic Vraylar

Indications in schizophrenia, bipolar disorder

The FDA recently approved Vraylar (cariprazine) capsules to treat schizophrenia and bipolar disorder (BD) in adults.

Indications: Vraylar is an atypical antipsychotic indicated for the treatment of schizophrenia and acute treatment of manic or mixed episodes associated with BD.

Dosage and administration: Administer Vraylar once daily with or without food. For both schizophrenia and bipolar mania, starting dose is 1.5 mg/day. The recommended dose for schizophrenia is 1.5 to 6 mg/day. For bipolar mania it is 3 mg to 6 mg/day. Doses above 6 mg/day do not confer significant benefit, but increase the risk of dose-related adverse reactions.

Efficacy and safety: The efficacy of Vraylar in treating schizophrenia was demonstrated in 1,754 participants in three 6-week clinical trials, where it was shown to reduce the symptoms of schizophrenia compared to placebo. Efficacy in treating BD was shown in three 3-week clinical trials of 1,037 participants, where it reduced symptoms.

Side effects/risks: Vraylar has a Boxed Warning about an increased risk of death associated with its use in older people with dementia-related psychosis. It is not approved to treat such patients.

The most common side effects are extrapyramidal symptoms, akathisia, dyspepsia, vomiting, somnolence, and restlessness.

Source: Highlights of Prescribing Information. Accessed September 23, 2015. Accessed September 23, 2015.