Safety and Efficacy of Cariprazine in FDA-Approved Dose Ranges for Schizophrenia and Bipolar I Disorder: A Pooled Post Hoc Analysis

January 24, 2017

This poster was presented at the 29th Annual U.S. Psychiatric & Mental Health Congress, held October 21-24, 2016, in San Antonio, Texas.

Introduction: Efficacy and tolerability of cariprazine in schizophrenia (SZ) and bipolar I disorder (BD) were demonstrated in Phase II/III clinical trials; some studies included doses outside the FDA-recommended dose range (SZ=1.5-6.0 mg/d; BD=3-6 mg/d). Post hoc analyses evaluated cariprazine safety within the recommended dose range.
Methods: Data from four 6-week SZ trials (n=1698) and three 3-week BD trials (n=705) were pooled by indication; safety analyses were based on cariprazine modal daily doses (SZ: 1.5-3 and 4.5-6 mg/d; BD: 3-6 mg/d). Safety parameters were evaluated including adverse events [AEs], physical and laboratory findings, and extrapyramidal symptoms.
Results: Cariprazine demonstrated significant improvement versus placebo on the primary outcome in 3 of 4 SZ trials (PANSS total score; P<.01) and 3 BD trials (YMRS total score; P<.001). Discontinuation rates due to AEs in the placebo and cariprazine groups, respectively, were 12% and 10% in SZ, and 7% and 11% in BD. In SZ or BD, common treatment-emergent AEs (≥5% and twice placebo) were akathisia, extrapyramidal disorder, tremor, restlessness, and vomiting. Serious AEs were similar for cariprazine and placebo. Mean changes in body weight were small (≤1 kg) and metabolic parameters were generally similar between groups; in BD, greater increases for cariprazine 3-6 mg/d versus placebo were seen in glucose (6.6 vs 1.7 mg/dL) and triglycerides (+8.7 vs -4.4 mg/dL). Mean prolactin levels decreased in all groups in both indications.
Conclusions: In post hoc pooled analysis, cariprazine was generally safe, well-tolerated, and efficacious in the FDA-recommended dose ranges in patients with SZ and BD.    

Willie Earley, MD; Suresh Durgam, MD; Kaifeng Lu, PhD; György Németh, MD; Akshar Patel, MD; István Laszlovszky, PharmD, PhD
Sponsoring Organization: 
Allergan, Inc., and Gedeon Richter Plc
Presented By: 
Akshar Patel, MD, Medical Scientific Manager, Allergan, Inc., Jersey City, NJ
Mood Disorders