Pivotal studies
Study 11,25
Study 21,26
Study 31,27
  • It is unknown if the statistically significant differences observed at time points earlier than Week 6 represent clinically relevant treatment effects
  • Maximum recommended dose of VRAYLAR is 6 mg/day. Doses above 6 mg daily do not confer increased effectiveness sufficient to outweigh dose-related adverse reactions1

Three 6-week, randomized, double-blind, placebo-controlled studies evaluating the efficacy and safety of VRAYLAR in adult patients (18-60 years old) with acute exacerbation of schizophrenia, based on DSM-IV-TR criteria. The primary statistical analyses were conducted using the LOCF approach for Study 1 and an MMRM approach for Study 2 and Study 3. In each study, the primary endpoint was the LS mean change from baseline in PANSS total score at the end of Week 6.1,25-27

*The approval of VRAYLAR for the treatment of schizophrenia was based on the change from baseline in total score, not individual symptom measurement, on the PANSS.1

DSM=Diagnostic and Statistical Manual of Mental Disorders; LOCF=last observation carried forward; LS=least squares; MMRM=mixed-effects model for repeated measures; PANSS=Positive and Negative Syndrome Scale; TR=text revision.

Long-term maintenance treatment of schizophrenia in adults was assessed in a 92-week study of VRAYLAR1,28

Following a 20-week, open-label phase on a stable dose of VRAYLAR, patients were randomized to VRAYLAR 3–9 mg/day or placebo for a 72-week, double-blind phase.1,28

Kaplan-Meier curves for schizophrenia relapse rate over 72 weeks1,28

Patients on VRAYLAR showed significantly longer time to relapse vs placebo at 72 weeks1,28

3 simple takeaways from the 72-week double-blind period1,2,28

Patients remaining on VRAYLAR had a 48% lower risk of relapse vs placebo[(hazard ratio=0.52; 95% CI: 0.33, 0.82) P=0.0039]

After one year, 35% of VRAYLAR patients relapsed vs 56% of placebo patients

Observed incidence of relapse was similar until approximately Week 6 (Day 44)

A long-term, 92-week, randomized withdrawal study that included a 20-week open-label phase and a 72-week double-blind placebo-controlled phase. Adult patients who met DSM-IV-TR criteria for schizophrenia (n=765) and who were clinically stable following 20 weeks of open-label VRAYLAR at doses of 3–9 mg/day were then randomized to receive either placebo (n=99) or VRAYLAR (n=101) at the same dose for up to 72 weeks in the double-blind phase. The primary endpoint was time to relapse.1,28

  • Recommended dose range of VRAYLAR is 1.5–6 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

CI=confidence interval.