Vraylar Receives Expanded Indication
May 28, 2019 – The U.S. FDA has approved an expanded indication for Vraylar® (cariprazine), manufactured by Allergan. It is now indicated to treat depressive episodes associated with bipolar I disorder (bipolar depression) in adults.
Bipolar disorder, which is categorized by symptoms, affects an estimated 11 million people in the United States. Patients who have bipolar I disorder experience manic episodes lasting at least seven days or severe enough to require immediate hospitalization. Patients also tend to experience depressive episodes that last for at least two weeks, and may have depressive episodes with mixed features, meaning manic symptoms are also present during the episode.
In clinical trials, patients who received Vraylar achieved greater improvement compared to baseline, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS), than those who received a placebo. Recommended dosing for the treatment of bipolar depression is 1.5mg once daily to start. If needed, the dose can be increased to 3mg once daily. The daily dose for bipolar depression should not exceed 3mg.
A black box warning cautions that there is an increased risk of death for elderly patients with dementia-related psychosis who are treated with antipsychotic drugs. The black box warning also cautions that antidepressants can increase the risk of suicidal ideation and behaviors in pediatric and young adult patients. Patients should be closely monitored for clinical worsening and emergence of suicidal ideation and behavior. The safety and efficacy of Vraylar in pediatric patients has not been established.
First FDA approved in 2015, Vraylar is also indicated to treat schizophrenia, as well as to provide acute treatment of manic or mixed episodes associated with bipolar I disorder, in adults.