FDA gives the green light for cariprazine to treat schizophrenia or bipolar disorder

US Food and Drug Administration

The US Food and Drug Administration has approved the atypical antipsychotic cariprazine (Vraylar) to treat adults with schizophrenia or bipolar disorder. 

Vraylar, an oral, once daily antipsychotic, is approved for the acute treatment of adult patients with manic or mixed episodes associated with bipolar I disorder, with a recommended dose range of 3–6mg/day and for the treatment of schizophrenia in adults, with a recommended dose range of 1.5–6mg per day. 

Common side effects for patients administered cariprazine with schizophrenia included tremor, slurred speech and involuntary muscle movement. For those patients with bipolar, the most common side effects from the drug were the urge to move, indigestion, vomiting, drowsiness and restlessness. 

Although the FDA has approved the product for adults, it has not been given the go ahead for the treatment of older patients with dementia-related psychosis because of an associated risk of death with this group. Cariprazine carries a boxed warning reflecting this restriction. 

Cariprazine does not have a marketing authorisation in the European Union, according to the EU’s medicines safety watchdog the European Medicines Agency (EMA). According to the EMA, the product is not in the process of being approved.

Last updated
The Pharmaceutical Journal, PJ, October 2015, Vol 295, No 7882;295(7882):DOI:10.1211/PJ.2015.20069435

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