Proven antimanic efficacy for bipolar I manic or mixed episodes1,19-21

Significant change in YMRS total score in bipolar manic or mixed episodes studies1,19-21

Study 4 (N=492)1,19

Study 5 (N=235)1,20

Study 6 (N=310)1,21

  • 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 did not appear to have additional benefit over lower doses and a dose-related increase in certain adverse reactions was observed1

Three 3-week, randomized, double-blind, placebo-controlled studies evaluating 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 3.1,19-21

DSM=Diagnostic and Statistical Manual of Mental Disorders; LOCF=last observation carried forward; LS=least squares; MMRM=mixed-effects model for repeated measures; TR=text revision; YMRS=Young Mania Rating Scale.

Post-hoc analysis of pooled data from VRAYLAR pivotal bipolar I manic or mixed episodes studies22

Observed reduction in all individual YMRS item scores at Week 322

YMRS CORE ITEMS (SCORED 0-8)

YMRS ITEMS (SCORED 0-4)

YMRS CORE ITEMS (SCORED 0-8)

Core mania symptoms are given double weight in calculating total score22

YMRS ITEMS (SCORED 0-4)

Because these analyses were not prespecified and were not adjusted for multiplicity, the results on the individual components require cautious interpretation and could represent chance findings.

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.22

  • VRAYLAR was approved based on the primary endpoint, mean change in YMRS total score from baseline at Week 31
  • Maximum recommended dose of VRAYLAR is 6 mg/day. Doses above 6 mg did not appear to have additional benefit over lower doses and a dose-related increase in certain adverse reactions was observed1

ITT=intent-to-treat.