VRAYLAR® (cariprazine) for the treatment of bipolar I disorder in adults with1:

When added to an antidepressant in adult patients with MDD, VRAYLAR delivers the POWER OF BOTH:

text alternative goes here

Proven Efficacy

In 6- and 8-week trials, VRAYLAR + antidepressant demonstrated:

  • Reduction in overall depressive symptoms1*†
  • Relief at lowest dose of 1.5 mg/day1*†
  • Flexibility to increase to 3 mg/day at Day 151*†

homepage-teal-arrow

text alternative goes here
text alternative goes here

Well-Established Tolerability1‡

In 6- and 8-week trials, VRAYLAR + antidepressant demonstrated:

  • Mean weight change of <2 lb§
  • Metabolic shifts similar to placebo for total cholesterol and fasting triglycerides||
  • 97% of patients did not have a clinically meaningful increase in blood glucose

homepage-purple-arrow

text alternative goes here

PROVEN EFFICACY

Reduction of overall depressive symptoms when added to antidepressant therapy (ADT) in 6- and
8-week MDD studies1*†

homepage-teal-arrow

text alternative goes here
text alternative goes here

WELL ESTABLISHED TOLERABILITY‡

In MDD clinical studies, most
patients taking VRAYLAR + ADT
saw no substantial impact on
weight,§ the proportion of patients
with metabolic shifts|| was also
similar to placebo, and there was no
meaningful increase in prolactin.1,2¶

homepage-purple-arrow

APPROVED IN 4 INDICATIONS

text alternative goes here

Evaluated in
12 clinical trials1

text alternative goes here

~6700 clinical
trial patients1

text alternative goes here

~7 years of real-world
experience1

**In a 6-week, placebo-controlled trial, mean change from baseline in MADRS total score at 6 weeks: VRAYLAR 1.5 mg/day + ADT (n=250): -14.1 (baseline mean: 32.8, P=0.0050); VRAYLAR 3 mg/day + ADT (n=252): -13.1 (baseline mean: 32.7, P=0.0727); placebo + ADT (n=249): -11.5 (baseline mean: 31.9).1,2

†In an 8-week, placebo-controlled trial, mean change from baseline in MADRS total score at 8 weeks: VRAYLAR 1-2 mg/day + ADT (n=273): -13.4 (baseline mean: 29.0, P=0.2404); VRAYLAR 2-4.5 mg/day + ADT (n=271): -14.6 (baseline mean: 29.3, P=0.0114); placebo + ADT (n=264): -12.5 (baseline mean: 28.9).1,2

‡‡The most common adverse reactions observed in the two 6-week MDD studies (≥5% and at least twice the rate of placebo) were akathisia, nausea, and insomnia. In the 6-week studies, 4% of the patients who received VRAYLAR discontinued treatment due to an adverse reaction, compared with 2% of placebo-treated patients in these trials.1,2

§Weight gain may occur. In two 6-week MDD studies, 2% of patients taking VRAYLAR + ADT had a weight increase of ≥7% vs 1% of those taking placebo + ADT. The mean weight changes reported in these studies were VRAYLAR 1.5 mg/day + ADT (n=502) =+1.54 lb; VRAYLAR 3 mg/day + ADT (n=503) =+1.54 lb; placebo + ADT (n=503) =+0.44 lb. In the 8-week MDD study, 2.5% of people taking VRAYLAR + ADT had a weight increase of ≥7% vs 2% of those taking placebo. The mean weight changes reported in this study were VRAYLAR 1-2 mg/day + ADT (n=273) =+1.98 lb; VRAYLAR 2-4.5 mg/day + ADT (n=273) =+1.98 lb; placebo + ADT (n=266) =0 lb. Monitor weight at baseline and frequently thereafter.1

‖In the 6- and 8-week MDD studies, proportion of patients with metabolic shifts was similar to placebo. Shift defined as: 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

In the 6-week studies, the proportion of patients with shifts in fasting glucose from normal (<100 mg/dL) to high (≥126 mg/dL): VRAYLAR 1.5 mg/day + ADT=2%; VRAYLAR 3 mg/day + ADT=3.2%; placebo-treated=1.3%. The proportion of patients with shifts in fasting glucose from normal to borderline (≥100 and <126 mg/dL) or from borderline to high was similar in patients treated with VRAYLAR and placebo. In the 8-week study, the shifts in fasting glucose were similar among the VRAYLAR and placebo + ADT groups.1

ADT=antidepressant therapy; MADRS=Montgomery-Asberg Depression Rating Scale.