Vraylar(cariprazine)

Vraylar (cariprazine) is an antipsychotic medication approved for several indications in adults. It is indicated for the treatment of schizophrenia, the acute treatment of manic or mixed episodes associated with bipolar I disorder, and the treatment of depressive episodes associated with bipolar I disorder (bipolar depression). On December 16, 2022, Vraylar received supplemental New Drug Application approval for a new indication: adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults.

In studies for major depressive disorder, the placebo-subtracted change in MADRS total score ranged from -1 to -2.5. The LS Mean Change from Baseline in MADRS total score for Cariprazine 1.5 mg was -14.07 (0.70) compared to -11.54 (0.70) for placebo. The dose-response slope for MADRS total score was -0.41. The recommended starting dose is 1.5 mg daily, with a recommended dose range of 1.5 mg to 6 mg daily, and a maximum recommended daily dosage of 6 mg or 3 mg depending on the indication.

Safety findings include Boxed Warnings for Increased Mortality in Elderly Patients with Dementia-Related Psychosis and Suicidal Thoughts and Behaviors. Common adverse reactions (incidence ≥ 5% and at least twice the rate of placebo) include extrapyramidal symptoms, akathisia, restlessness, dyspepsia, vomiting, somnolence, fatigue, constipation, nausea, insomnia, increased appetite, and dizziness. In 6-week schizophrenia trials, the mean change in body weight for VRAYLAR 1.5 - 3 mg/day was +0.8 kg, compared to +0.3 kg for placebo.