FDA approves Vraylar (cariprazine) for schizophrenia and bipolar disorder-Allergan

The FDA has approved Vraylar (cariprazine) capsules, from Allergan, to treat schizophrenia and bipolar disorder in adults. The efficacy of Vraylar in treating schizophrenia was demonstrated in 1,754 participants in three six-week clinical trials. In each of the trials, Vraylar was shown to reduce the symptoms of schizophrenia compared to placebo. The efficacy of Vraylar in treating bipolar disorder was shown in three three-week clinical trials of 1,037 participants. Vraylar was shown to reduce symptoms of bipolar disorder in each of the trials.

The most common side effects reported by participants receiving 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 Vraylar for bipolar disorder were extrapyramidal symptoms, the urge to move (akathisia), indigestion (dyspepsia), vomiting, drowsiness (somnolence) and restlessness.

Comment: This approval follows a refiling, after the FDA acknowledged that cariprazine clearly demonstrated effectiveness in the treatment of Schizophrenia and mania associated with Bipolar Disorder. However, the Agency indicated more information, including additional clinical trial data, would be needed.