The efficacy of Cariprazine (Vraylar) in treating schizophrenia was demonstrated in 1,754 participants in three six-week clinical trials. In each of the trials, Cariprazine (Vraylar) was shown to reduce the symptoms of schizophrenia compared to placebo. The efficacy of Cariprazine (Vraylar) in treating bipolar disorder was shown in three three-week clinical trials of 1,037 participants. Cariprazine (Vraylar) was shown to reduce symptoms of bipolar disorder in each of the trials.
Boxed Warning: Cariprazine (Vraylar) and all other FDA-approved drugs used to treat schizophrenia and bipolar disorder have a Boxed Warning alerting health care professionals about an increased risk of death associated with the use of these drugs in older people with dementia-related psychosis. Neither Cariprazine (Vraylar) nor any other drug in this class is approved to treat such patients. The most common side effects reported by participants receiving Cariprazine (Vraylar) 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 (Vraylar) for bipolar disorder were extrapyramidal symptoms, the urge to move (akathisia), indigestion (dyspepsia), vomiting, drowsiness (somnolence) and restlessness.