When adult major depressive disorder (MDD) patients with a partial response to an antidepressant (ADT) or bipolar I (BP-I) patients feel stuck, VRAYLAR can help them break through to relief—when added to an ADT for MDD and as monotherapy for depressive and acute manic/mixed episodes of BP-I.1
Proven to treat the most common forms of depression—major depressive disorder (adjunctive) and bipolar I depression1-3†
*October 2024 IQVIA data for both new-to-brand prescriptions (NBRx) and total prescriptions (TRx).
†Most common forms of depression that include a major depressive episode (MDE) according to DSM-5.
VRAYLAR is indicated in adults as adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD), for the treatment of depressive episodes associated with bipolar I disorder (bipolar depression), for the acute treatment of manic or mixed episodes associated with bipolar I disorder, and for the treatment of schizophrenia.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‡
Well-established tolerability§||
Safety profile studied across 5 clinical trials in MDD (adjunctive) and BP-I depression
In two 6-week adjunctive MDD trials, VRAYLAR + ADT demonstrated1,2:
In 3 BP-I depression trials1,2:
#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**††‡‡
†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 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
||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.1
¶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
#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.
Clinical and real-world experience across 4 indications
12
Clinical Trials Inclusive of All Indications1§§
OVER
1 MILLION
Patients Treated With VRAYLAR2||||
||||Since 2015. Inclusive of all indications.
100,000
Prescribing Clinicians2||||
§§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
VRAYLAR remains committed to supporting access and affordability for patients
92%of VRAYLAR patients pay
$10or less per 30-day prescription2¶¶
Lower out-of-pocket cost may mean patients are more likely to stay on track with their treatment4##
¶¶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 November 2023-October 2024. Patient’s actual out-of-pocket cost may vary depending on their insurance coverage and eligibility for support programs.
##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 healthcare 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.4
ADT=antidepressant therapy; AE=adverse event; BP-I=bipolar I disorder; DSM=Diagnostic and Statistical Manual of Mental Disorders; EPS=extrapyramidal symptoms; MDD=major depressive disorder; MOA=mechanism of action.
VRAYLAR (cariprazine) is indicated in adults as adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD), for the treatment of depressive episodes associated with bipolar I disorder (bipolar depression), for the acute treatment of manic or mixed episodes associated with bipolar I disorder, and for the treatment of schizophrenia.
WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS
Contraindication: VRAYLAR is contraindicated in patients with known hypersensitivity. Reactions have included rash, pruritus, urticaria, and reactions suggestive of angioedema.
Cerebrovascular Adverse Reactions, Including Stroke: In clinical trials with antipsychotic drugs, elderly patients with dementia had a higher incidence of cerebrovascular adverse reactions, including fatalities, vs placebo. VRAYLAR is not approved for the treatment of patients with dementia-related psychosis.
Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal symptom complex, has been reported with antipsychotic drugs. NMS may cause hyperpyrexia, muscle rigidity, delirium, and autonomic instability. Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. Manage with immediate discontinuation, intensive symptomatic treatment, and monitoring.
Tardive Dyskinesia (TD): Risk of developing TD (a syndrome of potentially irreversible, involuntary, dyskinetic movements) and the likelihood it will become irreversible may increase with the duration of treatment and the cumulative dose. The syndrome can develop after a relatively brief treatment period, even at low doses, or after treatment discontinuation. If signs and symptoms of TD appear, drug discontinuation should be considered.
Late-Occurring Adverse Reactions: Adverse reactions may first appear several weeks after initiation of VRAYLAR, probably because plasma levels of cariprazine and its major metabolites accumulate over time. As a result, the incidence of adverse reactions in short-term trials may not reflect the rates after longer-term exposures. Monitor for adverse reactions, including extrapyramidal symptoms (EPS) or akathisia, and patient response for several weeks after starting VRAYLAR and after each dosage increase. Consider reducing the dose or discontinuing the drug.
Metabolic Changes: Atypical antipsychotics, including VRAYLAR, have caused metabolic changes, such as:
Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia/neutropenia have been reported with antipsychotics, including VRAYLAR. Agranulocytosis (including fatal cases) has been reported with other antipsychotics. Monitor complete blood count in patients with pre-existing low white blood cell count (WBC)/absolute neutrophil count or history of drug-induced leukopenia/neutropenia. Discontinue VRAYLAR at the first sign of a clinically significant decline in WBC and in severely neutropenic patients.
Orthostatic Hypotension and Syncope: Atypical antipsychotics cause orthostatic hypotension and syncope, with the greatest risk during initial titration and with dose increases. Monitor orthostatic vital signs in patients predisposed to hypotension and in those with cardiovascular/cerebrovascular diseases.
Falls: VRAYLAR may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries. For patients with diseases, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating antipsychotics and recurrently for patients on long-term therapy.
Seizures: Use VRAYLAR with caution in patients with a history of seizures or with conditions that lower the seizure threshold.
Potential for Cognitive and Motor Impairment: Somnolence was reported with VRAYLAR. Caution patients about performing activities requiring mental alertness (eg, operating hazardous machinery or a motor vehicle).
Body Temperature Dysregulation: Use VRAYLAR with caution in patients who may experience conditions that increase body temperature (eg, strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics).
Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotics. Antipsychotic drugs, including VRAYLAR, should be used cautiously in patients at risk for aspiration.
Drug Interactions: Strong and moderate CYP3A4 inhibitors increase VRAYLAR concentrations, so VRAYLAR dose reduction is recommended. Concomitant use with CYP3A4 inducers is not recommended.
Adverse Reactions: The most common adverse reactions in clinical trials (≥5% and at least twice the rate of placebo) are listed below:
US-VRA-240286
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