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Proven effective in improving overall manic or mixed episodes of bipolar I1-4
Significant change in YMRS total score in bipolar I acute manic or mixed episodes studies
Study 4 (N=492)1,2
It is unknown if the statistically significant differences observed at time points earlier than Week 3 represent clinically relevant treatment effects.
Maximum recommended dose of VRAYLAR is 6 mg/day. Doses above 6 mg daily did not appear to have additional benefit over lower doses and a dose-related increase in certain adverse reactions was observed.1
Three 3-week, randomized, double-blind, placebo-controlled studies evaluated the efficacy and safety of VRAYLAR in adult patients (18-65 years old) with manic or mixed episodes of bipolar I disorder, with or without psychotic features, based on DSM-IV-TR criteria. The primary statistical analyses were conducted using an MMRM approach for Study 4 and Study 6 and the LOCF approach for Study 5. In each study, the primary endpoint was the LS mean change from baseline in YMRS total score at the end of Week 3.1-4
Significant change in YMRS total score in bipolar I acute manic or mixed episodes studies
Study 5 (N=235)1,3
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It is unknown if the statistically significant differences observed at time points earlier than Week 3 represent clinically relevant treatment effects.
Maximum recommended dose of VRAYLAR is 6 mg/day. Doses above 6 mg daily did not appear to have additional benefit over lower doses, and a dose-related increase in certain adverse reactions was observed.
Three 3-week, randomized, double-blind, placebo-controlled studies evaluated the efficacy and safety of VRAYLAR in adult patients (18-65 years old) with manic or mixed episodes of bipolar I disorder, with or without psychotic features, based on DSM-IV-TR criteria. The primary statistical analyses were conducted using an MMRM approach for Study 4 and Study 6 and the LOCF approach for Study 5. In each study, the primary endpoint was the LS mean change from baseline in YMRS total score at the end of Week 3.1-4
Significant change in YMRS total score in bipolar I acute manic or mixed episodes studies
Study 6 (N=310)1,4
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It is unknown if the statistically significant differences observed at time points earlier than Week 3 represent clinically relevant treatment effects.
Maximum recommended dose of VRAYLAR is 6 mg/day. Doses above 6 mg daily did not appear to have additional benefit over lower doses, and a dose-related increase in certain adverse reactions was observed.
Three 3-week, randomized, double-blind, placebo-controlled studies evaluated the efficacy and safety of VRAYLAR in adult patients (18-65 years old) with manic or mixed episodes of bipolar I disorder, with or without psychotic features, based on DSM-IV-TR criteria. The primary statistical analyses were conducted using an MMRM approach for Study 4 and Study 6 and the LOCF approach for Study 5. In each study, the primary endpoint was the LS mean change from baseline in YMRS total score at the end of Week 3.1-4
Observed reduction in all individual YMRS item scores at Week 3 in a post-hoc analysis5
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Core mania symptoms are given double weight in calculating total score.5
The analyses were not prespecified endpoints and were not adjusted for multiplicity. Therefore, treatment differences cannot be regarded as statistically significant.
VRAYLAR was approved based on the primary endpoint, mean change in YMRS total score from baseline at Week 3.1
Maximum recommended dose of VRAYLAR is 6 mg/day. Doses above 6 mg daily did not appear to have additional benefit over lower doses and a dose-related increase in certain adverse reactions was observed.1
A post-hoc analysis of data pooled from 3 similarly designed, randomized, placebo-controlled, double-blind, multicenter, parallel-group studies of adult patients with bipolar I disorder. Patients in the ITT population (N=1037) were treated with either placebo (n=429) or VRAYLAR (n=608). VRAYLAR doses 3–12 mg/day were pooled for analysis. Mean change from baseline at 3 weeks on individual YMRS items was analyzed using an MMRM approach.5
DSM=Diagnostic and Statistical Manual of Mental Disorders; ITT=intent-to-treat; LOCF=last observation carried forward; LS=least squares; MMRM=mixed-effects model for repeated measures; TR=text revision; YMRS=Young Mania Rating Scale.