Medication Monitor



Generic Name (Trade Name—Company)
Notes
June 13, 2019

Cariprazine

(Vraylar—Allergan, Gedeon Richter)
FDA approves expanded use of caprizine to treat bipolar depression

Allergan and Gedeon Richter announced FDA approval of cariprazine, an oral, once-daily, atypical antipsychotic, for expanded use to treat depressive episodes associated with bipolar I disorder  in adults (1.5 or 3 mg/day). Cariprazine is also approved in the United States to treat manic or mixed episodes associated with bipolar I disorder in adults (3–6 mg/d). 

Approval for the expanded indication was based on three pivotal trials, including RGH-MD-53, RGH-MD-54 and RGH-MD-56, in which cariprazine demonstrated greater improvement than placebo for the change from baseline to week six on the Montgomery Asberg Depression Rating scale total score. In all three studies, the cariprazine 1.5-mg dose demonstrated statistical significance over placebo. In addition, in RGH-MD-54, the cariprazine 3-mg dose demonstrated statistical significance over placebo.

Common adverse events reported in the pivotal trials were nausea, akathisia, restlessness, and extrapyramidal symptoms.