Schizophrenia

VRAYLAR significantly improved

Overall Schizophrenia Symptoms1,13-15*

Change in PANSS total score in schizophrenia studies1,13-15

Study 1 Study 1
Study 2 Study 2
Study 3 Study 3

Study 11,13

Graph showing change in PANSS total score in VRAYLAR vs placebo for schizophrenia in study 1.

Study 21,14

Graph showing change in PANSS total score in VRAYLAR vs placebo for schizophrenia in study 2.

Study 31,15

Graph showing change in PANSS total score in VRAYLAR vs placebo for schizophrenia in study 3.

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 did not appear to have additional benefit over lower doses and a dose-related increase in certain adverse reactions was observed.1

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 6.1,13-15

*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 VRAYLAR1,16

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.1,16

Kaplan-Meier curves for schizophrenia relapse rate over 72 weeks1,16

Graph of VRAYLAR long-term study results for the treatment of schizophrenia in adults.

Patients on VRAYLAR showed significantly longer time to relapse vs placebo at 72 weeks1,16

3 simple takeaways from the 72-week double-blind period1,2,16

1 icon.

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]

2 icon.

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

3 icon.

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.1,16

Relapse in the withdrawal study was defined as meeting any one of the following criteria: hospitalization due to worsening of schizophrenia, increase in the PANSS total score by ≥30%, increase in the PANSS total score by ≥2 points, deliberate self-injury, aggressive or violent behavior, clinically significant suicidal or homicidal ideation, or score >4 on one or more of the following PANSS items: delusions, conceptual disorganization, hallucination, suspiciousness or persecution, hostility, uncooperativeness, or poor impulse control.1,16

Recommended dose range of VRAYLAR is 1.5-6 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

CI=confidence interval.

 

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