For your bipolar I patients, VRAYLAR can help them go from getting through to breaking through
When adult patients with bipolar I feel stuck, VRAYLAR can help them break through to relief for all bipolar I symptoms in depressive and acute manic or mixed episodes.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
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†
- Full-spectrum relief for all BP-I symptoms in depressive and acute manic or mixed episodes in adults1‡
Well-established tolerability§
In 3 BP-I depression trials1,2:
- Mean weight change of 1.5 lb||
- Somnolence and sedation rates similar to placebo (PBO 4%, 1.5 mg 7%, 3 mg 6%)
- Common AEs ≥5% and at least twice that of placebo included nausea, akathisia, restlessness, and EPS
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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¶#**
*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 BP-I depression was evaluated in 3 trials in adult BP-I patients. In Study 7 (8 weeks), LS mean change from baseline to Week 6 in MADRS total score (primary endpoint) was -15.1 (VRAYLAR 1.5 mg/day; n=145) vs -11.1 (placebo; n=141), P<0.05; -13.7 for VRAYLAR 3 mg/day (n=145; dose was not statistically significant). In Study 8 (6 weeks), LS mean change from baseline to Week 6 in MADRS total score (primary endpoint) was -15.1 (VRAYLAR 1.5 mg/day; n=154) and -15.6 (VRAYLAR 3 mg/day; n=164) vs -12.6 (placebo; n=156), P<0.05. In Study 9 (6 weeks), LS mean change from baseline to Week 6 in MADRS total score (primary endpoint) was -14.8 (VRAYLAR 1.5 mg/day; n=162) vs -12.4 (placebo; n=163), P<0.05; -14.1 for VRAYLAR 3 mg/day (n=153; dose was not statistically significant). The efficacy of VRAYLAR in acute manic or mixed episodes associated with BP-I disorder was studied in 3 trials in adult BP-I patients. In Study 4 (3 weeks), LS mean change from baseline to Week 3 in YMRS total score (primary endpoint) was -18.6 (VRAYLAR 3-6 mg/day; n=165) and -18.5 (VRAYLAR 6-12 mg/day; n=167) vs -12.5 (placebo; n=160), P<0.05. In Study 5 (3 weeks), LS mean change from baseline to Week 3 in YMRS total score (primary endpoint) was -15.0 (VRAYLAR 3-12 mg/day; n=118) vs -8.9 (placebo; n=117), P<0.05. In Study 6 (3 weeks), LS mean change from baseline to Week 3 in YMRS total score (primary endpoint) was -19.6 (VRAYLAR 3-12 mg/day; n=158) vs -15.3 (placebo; n=152), P<0.05. 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
§The most common adverse reactions in BP-I depression studies (≥5% and at least twice that of placebo) were nausea, akathisia, restlessness, and EPS. In these studies, 6% of VRAYLAR-treated patients discontinued treatment due to an adverse reaction, versus 5% of placebo-treated patients. The most common adverse reactions in BP-I manic or mixed studies (≥5% and at least twice that of placebo) were EPS, akathisia, vomiting, dyspepsia, somnolence, and restlessness. In these studies, 12% of VRAYLAR-treated patients discontinued treatment due to an adverse reaction, versus 7% of placebo-treated patients.1
||Weight gain may occur. In BP-I depression studies, 3% of people taking VRAYLAR had a weight increase of ≥7% vs 1% of those taking placebo. The mean weight changes reported in these studies were VRAYLAR 1.5 mg/day (n=467) = +1.5 lb; VRAYLAR 3 mg/day (n=465) = +0.9 lb; placebo (n=463) = -0.2 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 BP-I patients
††Data from a survey of 293 healthcare professionals in the US (not including VT or MN), who managed ≥2 BP-I patients over the past month and managed BP-I patients treated with oral atypical antipsychotics over the past month. When asked how likely they would be to recommend VRAYLAR (cariprazine) for the treatment of bipolar I disorder in adults if asked for a recommendation by a colleague, 270 out of 293 respondents (92.2%) 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
Screening is an important first step in obtaining a proper diagnosis of bipolar I disorder
The Rapid Mood Screener (RMS) is a mood screener that uses patient-reported answers to help uncover bipolar I disorder.4‡‡
‡‡Disclaimer: AbbVie funded and contributed to the development of this screening tool. This screening tool is not a diagnostic tool. Other screening tools for bipolar I disorder are available, such as the Mood Disorder Questionnaire (MDQ)
VRAYLAR is proven to treat the most common forms of depression—bipolar I depression and major depressive disorder (adjunctive).1-3*
*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; EPS=extrapyramidal symptoms; LS=least squares; MADRS=Montgomery-Asberg Depression Rating Scale; MDD=major depressive disorder; MOA=mechanism of action; PBO=placebo; YMRS=Young Mania Rating Scale.