For adult MDD partial responders, Adding VRAYLAR to an antidepressant can help them go from getting through to breaking through

When adult major depressive disorder (MDD) patients with a partial response to their antidepressant (ADT) feel stuck with lingering depressive symptoms, adding VRAYLAR to an ADT can help them break through to relief.1

Adaptive receptor activity to modulate dopamine and serotonin

VRAYLAR is the only partial agonist approved for MDD (adjunctive) and BP-I depressive and acute manic or mixed episodes in adults1

The mechanism of action of VRAYLAR is unknown. The efficacy is thought to be mediated through a combination of partial agonist activity at central dopamine D2 and serotonin 5-HT1A receptors and antagonist activity at serotonin 5-HT2A receptors.1

Review MOA

Robust evidence in the most common forms of depression‌1-3*

  • Across 4 clinical trials, VRAYLAR is proven to treat MDD (adjunctive) and BP-I depression at the lowest dose (1.5 mg/day)1†
  • In MDD trials, VRAYLAR + ADT was shown to reduce overall depressive symptoms, providing a boost of additional antidepressant efficacy at 6 and 8 weeks1,2,4‡
Review efficacy

Well-established tolerability§

In two 6-week adjunctive MDD trials, VRAYLAR + ADT demonstrated1,2:

  • Mean weight change of 1.5 lb||
  • Somnolence and sedation rates similar to placebo (PBO + ADT 4%, 1.5 mg + ADT 5%, 3 mg + ADT 6%)
  • Common AEs ≥5% and at least twice that of placebo included insomnia, nausea, and akathisia
Review safety

#1

Leading the way in unrestricted patient access

VRAYLAR has the #1 unrestricted combined coverage across all channels, inclusive of commercial, Medicare Part D, and Medicaid, among branded oral atypical antipsychotics2¶#**

See local coverage

*Most common forms of depression that include a major depressive episode (MDE) according to DSM-5.

†Starting dose is 1.5 mg/day. May increase dose to 3 mg/day on day 15, depending on clinical response and tolerability.1

‡The efficacy of VRAYLAR in adjunctive MDD was evaluated in 2 trials in adult MDD patients with an inadequate response to 1 to 3 courses of prior antidepressant (ADT) therapy. In the 6-week trial, LS mean change from baseline in MADRS total score (primary endpoint) was -14.1 (VRAYLAR 1.5 mg/day + ADT; n=250) vs -11.5 (placebo + ADT; n=249), P<0.05; -13.1 for VRAYLAR 3 mg/day + ADT (n=252; dose was not statistically significant). In the 8-week trial, LS mean change from baseline in MADRS total score (primary endpoint) was -14.6 (VRAYLAR 2-4.5 mg/day + ADT; n=271) vs -12.5 (placebo + ADT; n=264), P<0.05; -13.4 for VRAYLAR 1-2 mg/day + ADT (n=273; dose was not statistically significant).1

§The most common adverse reactions in 6-week adjunctive MDD studies (≥5% and at least twice that of placebo) were akathisia, nausea, and insomnia. In these studies, 4% of VRAYLAR-treated patients discontinued treatment due to an adverse reaction, versus 2% of placebo-treated patients.1,2

||Weight gain may occur. In two 6-week MDD studies, 2% of people taking VRAYLAR + ADT had a weight increase of ≥7% vs 1% of those taking placebo + ADT. The mean weight changes reported in this study were VRAYLAR 1.5 mg/day + ADT (n=502) = +1.5 lb; VRAYLAR 3 mg/day + ADT (n=503) = +1.5 lb; placebo + ADT (n=503) = +0.4 lb.1

Excluding branded products that have available generics.

#Unrestricted implies no step edit.

**Source: Managed Markets Insight and Technology, LLC, a trademark of MMIT. Database as of May 2025. Applicable to the atypical antipsychotic market basket. Coverage requirements and benefit designs vary by payer and may change over time. Please consult with payers directly for the most current reimbursement policies.

In a survey of healthcare professionals who manage MDD patients

88 percent.

of those who prescribe VRAYLAR would likely recommend it as an adjunctive treatment for MDD to a colleague2††

††Data from a survey of 381 healthcare professionals in the US (not including VT or MN), who managed ≥15 MDD patients over the past month and managed MDD patients using atypical antipsychotics as adjunctive treatment over the past 1 month. When asked how likely they would be to recommend VRAYLAR (cariprazine) for the adjunctive treatment of MDD in adults if asked for a recommendation by a colleague, 314 out of 358 respondents (88%) answered between 6 and 10 on a scale of 0-10, with 0 being “Not at All Likely to Recommend” and 10 being “Extremely Likely to Recommend.”2

VRAYLAR is proven to treat the most common forms of depression—major depressive disorder (adjunctive) and bipolar I depression.1-3*

Learn about BP-I

*Most common forms of depression that include a major depressive episode (MDE) according to DSM-5.

ADT=antidepressant therapy; AE=adverse event; BP-I=bipolar I disorder; DSM=Diagnostic and Statistical Manual of Mental Disorders; LS=least squares; MADRS=Montgomery-Asberg Depression Rating Scale; MDD=major depressive disorder; MOA=mechanism of action; PBO=placebo.