Major Depressive Disorder

When added to an antidepressant in adult MDD patients, VRAYLAR delivers

The Power of Both

Proven efficacy* and well-established tolerability

Learn about VRAYLAR in MDD

See more below

Bipolar I Disorder

Full-Spectrum Relief

For all bipolar I symptoms in depressive and acute manic or mixed episodes in adults

Learn about VRAYLAR in BP-I

The First & Only dopamine and serotonin partial agonist FDA approved for the most common forms of depression—MDD (adjunctive) and bipolar I depression1

VRAYLAR is approved across 4 indications


VRAYLAR (cariprazine) indication approval timeline.
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2015

Bipolar I acute manic/mixed

Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults1


Schizophrenia

Treatment of schizophrenia in adults1

2019

Bipolar I depression

Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults1

2022

Major depressive disorder

Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults1

Around 8 years of real-world experience.

years of real-world experience1

12 clinical trials inclusive of all indications.

clinical trials inclusive
of all indications

Around 6,700 clinical trial patients.

clinical trial patients1

Since 2015, 1 million patients have been treated with VRAYLAR.

Since 2015. Inclusive of all indications. Source: IQVIA 09/23.

*In clinical trials, VRAYLAR + antidepressant reduced overall depressive symptoms. In the 6-week trial, mean change from baseline in MADRS total score was -14.1 (VRAYLAR 1.5 mg/day + ADT) vs -11.5 (placebo + ADT) P<0.05; -13.1 for VRAYLAR 3 mg/day + ADT (dose was not statistically significant). In the 8-week trial, mean change from baseline in MADRS total score was -14.6 (VRAYLAR 2-4.5 mg/day + ADT) vs -12.5 (placebo + ADT) P<0.05; -13.4 for VRAYLAR 1-2 mg/day + ADT (dose was not statistically significant).1,2

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 See additional safety information below.

The mechanism of action of cariprazine is unknown. However, the efficacy of cariprazine could 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.

§The most common adverse reactions observed in VRAYLAR trials (≥5% and at least twice the rate of placebo): major depressive disorder (two 6-week studies) (VRAYLAR 1.5 mg/day + ADT or 3 mg/day + ADT vs placebo + ADT)— akathisia (7%, 10% vs 2%), nausea (7%, 6% vs 3%), and insomnia (9%, 10% vs 5%); bipolar I depression (VRAYLAR 1.5 mg/day or 3 mg/day vs placebo)-nausea (7%, 7% vs 3%), akathisia (6%, 10% vs 2%), restlessness (2%, 7% vs 3%), and EPS (4%, 6% vs 2%); bipolar I mania (VRAYLAR 3-6 mg/day vs placebo)—EPS (26% vs 12%), akathisia (20% vs 5%), vomiting (10% vs 4%), dyspepsia (7% vs 4%), somnolence (7% vs 4%), and restlessness (7% vs 2%); schizophrenia (VRAYLAR 1.5-3 mg/day and 4.5-6 mg/day vs placebo)—EPS (15%, 19% vs 8%) and akathisia (9%, 13% vs 4%).1

ADT=antidepressant therapy; EPS=extrapyramidal symptoms; MDD=major depressive disorder.


VRAYLAR remains committed to supporting access and affordability for patients

94% of VRAYLAR patients pay $10 or less per prescription.

of VRAYLAR patients pay $10 or less per prescription2

Lower out-of-pocket cost may mean patients are more likely to stay on track with their treatment31¶

Based upon paid Commercial, Medicare Part D, Medicaid, Cash/Savings Card, and Federal claims data from national providers for a filled VRAYLAR prescription for the period June 2023-August 2023.

Patients actual out-of-pocket cost may vary depending on their insurance coverage and eligibility for support programs.

Lower out-of-pocket cost may mean patients are more likely to stay on track with their treatment31¶

Based upon paid Commercial, Medicare Part D, Medicaid, Cash/Savings Card, and Federal claims data from national providers for a filled VRAYLAR prescription for the period June 2023-August 2023.

Patients actual out-of-pocket cost may vary depending on their insurance coverage and eligibility for support programs.

Covered on top national commercial plans2#:

  • Express Scripts
  • CVS Health/Caremark
  • UnitedHealthcare
  • TRICARE
  • Cigna
  • Elevance (Anthem)
  • Aetna
  • OptumRX

Source: MAT August 2023.

The objective of the systematic literature review of 71 articles published between January 2010 and August 2020 was to assess the impact of patient drug cost-sharing on medication adherence, clinical outcomes, resource utilization and health care costs. The analysis observed increased cost-sharing was associated with worse adherence (84% of studies), persistence (79% of studies), or discontinuation (58% of studies). Limitations include that the type (eg, deductible, coinsurance, and copay) and magnitude (eg, $5, $50, or >$5,000 deductible) of cost-sharing were not homogeneous and outcome definitions varied (eg, proportion of days covered, medication possession ratios, or specific thresholds for treatment adherence, etc), making comparisons across publications difficult.31

#Coverage requirements and benefit design vary by payer and may change over time. Please consult with payers directly for the most current reimbursement policies.

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Talk to your patients about the VRAYLAR Savings Program.