FDA approves Vraylar for schizophrenia, bipolar disorder

The FDA today approved Vraylar to treat schizophrenia and bipolar disorder in adults, according to a press release.

Efficacy of Vraylar (cariprazine, Forest Laboratories) for schizophrenia was analyzed among 1,754 study participants in three 6-week clinical trials. In each of the trials, Vraylar reduced symptoms of schizophrenia compared with placebo.

The most common adverse effects reported by participants who received Vraylar for schizophrenia were extrapyramidal symptoms, including tremor, slurred speech and involuntary muscle movements.

Vraylar was assessed for bipolar disorder among 1,037 study participants in three 3-week clinical trials and was shown to reduce bipolar disorder symptoms in each of these trials, according to the release.

The most common adverse effects reported by participants who received Vraylar for bipolar disorder included extrapyramidal symptoms, akathisia, indigestion, vomiting, drowsiness and restlessness.

Like all other FDA-approved drugs for schizophrenia and bipolar disorder, Vraylar has a Boxed Warning regarding increased risk for death associated with the use of these drugs among older individuals with dementia-related psychosis.

“Schizophrenia and bipolar disorder can be disabling and can greatly interfere with day-to-day activities,” Mitchell Mathis, MD, director of the Division of Psychiatry Products at the FDA’s Center for Drug Evaluation and Research. “It is important to have a variety of treatment options available to patients with mental illnesses so that treatment plans can be tailored to meet a patient’s individual needs.” – by Amanda Oldt