Pivotal studies

VRAYLAR metabolics, prolactin, and weight change in schizophrenia studies

Shifts from baseline to endpoint in pivotal studies1,2*

Weight change in 6-week pivotal studies1†‡

*Metabolic shift defined as: fasting glucose: normal (<100 mg/dL) to high (≥126 mg/dL), borderline (≥100 mg/dL and <126 mg/dL) to high; total cholesterol: normal/borderline (<240 mg/dL) to high (≥240 mg/dL); fasting triglycerides: normal/borderline (<200 mg/dL) to high (≥200 mg/dL).1,2

Data shown from baseline to endpoint (Week 6) by modal daily dose, defined as most frequently administered dose per patient.1,2

Recommended dose range of VRAYLAR is 1.5–6 mg/day for schizophrenia. Doses above 6 mg did not appear to have additional benefit over lower doses and a dose-related increase in certain adverse reactions was observed.1

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

  • 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

§Proportion of patients with weight gain ≥7% was 10.6% during the open-label phase and 27.0% and 32.3% for VRAYLAR and placebo-treated patients,
respectively, during the double-blind phase.28