AbbVie Highlights New Real-World Data Supporting the Effectiveness of VRAYLAR® (cariprazine) at Psych Congress 2026

• New data from prospective real-world studies of VRAYLAR showed meaningful improvements in depressive symptoms, functioning and quality of life among adults living with major depressive disorder (MDD) and bipolar I (BP-I) depression
• These findings provide additional evidence that the benefits observed with VRAYLAR in clinical trials can also be achieved in routine practice, where patients often have more complex treatment needs

NORTH CHICAGO, Ill., Sept. 18, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today presented new VRAYLAR^® (cariprazine) data at Psych Congress 2026 in New Orleans, including results from two prospective real-world observational studies in major depressive disorder (MDD) and bipolar I disorder (BP-I). The findings reinforce that the efficacy established in clinical trials translates to effectiveness in the broader, more clinically complex patient populations healthcare providers treat every day.

"Because mood disorders are highly heterogeneous, it is critical to evaluate treatments in real-world settings where care is delivered every day," said Mudra Kapoor, M.D., vice president, global medical affairs, AbbVie. "These prospective studies provide additional evidence that VRAYLAR can help patients achieve meaningful improvements in depressive symptoms, functioning and other patient-centered outcomes in routine clinical practice."

In the real-world BP-I depression study, CReW BP-I, patients treated with VRAYLAR experienced significant improvements in depressive symptoms as well as outcomes that affect daily life, including functioning and quality of life, after 12 weeks of treatment in routine clinical practice; the most common adverse events were nausea and dizziness. In ProACt, a real-world study of adjunctive VRAYLAR in MDD, interim findings showed improvements not only in depressive symptoms, but also in outcomes that affect day-to-day life and matter most to patients, including functioning, motivation, energy and anhedonia.

In addition to these real-world studies, AbbVie also presented an indirect comparative analysis in MDD, long-term pediatric safety data, and patient preference research evaluating treatment approaches following inadequate antidepressant response.

"For clinicians, one of the most important questions is whether the benefits demonstrated in clinical trials hold up in the real world, where patients have unique needs, experiences and treatment journeys," said Andrew J. Cutler, M.D., an author of the ProACt study, Clinical Professor of Psychiatry at SUNY Upstate Medical University and Chief Medical Officer of the Neuroscience Education Institute. "These studies reinforce what has been established in VRAYLAR clinical trials and provide additional confidence that meaningful improvements in symptoms, functioning and patient-reported outcomes can be achieved beyond the controlled environment of a trial. That kind of real-world validation is valuable when making individualized treatment decisions in everyday clinical practice."

MDD and BP-I can profoundly affect every aspect of a person's life and often require long-term, comprehensive care. Approximately one in five U.S. adults will experience MDD during their lifetime,¹ and nearly 11 million adults are living with bipolar disorder,² yet many continue to experience ongoing symptoms despite available treatments—highlighting persistent unmet treatment needs.

Additional Presentations at Psych Congress 2026:

• An anchored matching-adjusted indirect comparison evaluating the efficacy and safety of cariprazine and lumateperone as adjunctive treatment for inadequate antidepressant response in adults with MDD.
• Final results from a long-term, open-label study evaluating the safety and tolerability of VRAYLAR among pediatric patients with BP-I disorder, schizophrenia or autism spectrum disorder, which showed VRAYLAR was generally well tolerated in the age groups studied. The use of cariprazine in the treatment of autism is not FDA-approved.
• Results from an MDD patient survey showing that most patients preferred augmenting their existing antidepressant treatment rather than switching therapies following an inadequate response, underscoring the importance of having adjunctive treatment options available.

About VRAYLAR^®3

VRAYLAR^® (cariprazine) is a once-daily prescription medication approved as an add-on therapy for MDD in adults who are currently taking an antidepressant but still have unresolved depression symptoms, the acute treatment of manic or mixed episodes associated with BP-I in adults and pediatric patients 10 years of age and older, the treatment of depressive episodes associated with BP-I (bipolar depression) in adults, and for the treatment of schizophrenia in patients 13 years of age and older. VRAYLAR received FDA approval for certain pediatric populations and low doses (0.5 mg and 0.75 mg) in December of 2025, demonstrating continued innovation more than 10 years in. Since its approval in 2015, more than 150,000 clinicians have used VRAYLAR to treat more than 1.9 million patients across its indications.⁴ In a survey of healthcare professionals treating MDD and BP-I, 88% of VRAYLAR prescribers would recommend it as an adjunctive MDD treatment, while 92% would recommend it for BP-I.⁵

VRAYLAR was developed jointly by AbbVie and Gedeon Richter Plc, with AbbVie responsible for commercialization in the U.S., Canada, and certain other countries.

About CReW BP-I:⁶
This prospective, observational, real-world study evaluated VRAYLAR in 118 adults with BP-I depression, with or without mixed features. The efficacy analysis included 99 patients. Patients with a history of psychiatric conditions—including anxiety, trauma-related, depressive, and attention-related disorders—were included, ensuring the patient population is reflective of the patients clinicians are seeing in everyday practice. The study was an observational, single-arm study, and outcomes were assessed based on changes from baseline. At week 12, mean Montgomery-Åsberg Depression Rating Scale (MADRS) scores decreased from a baseline of 32.2 to 19.9 at week 12 (change, -12.92; p<0.0001), while Functional Assessment Short Test (FAST) scores decreased from 43.4 at baseline to 30.7 at week 12 (change, -13.11; p<0.0001). Exploratory measures of quality of life, manic symptoms, illness severity and patient-reported depression also improved (p<0.0001 for all measures). Nausea and dizziness were the most common treatment-emergent adverse events (5.1% each).

About ProACt:⁷
ProACt MDD is an ongoing, prospective, real-world, observational study evaluating adults with MDD who are initiating VRAYLAR as an adjunctive therapy to an antidepressant. Patients with a history of psychiatric conditions including anxiety disorders, trauma, sleep disorders and stress were included, ensuring the patient population is reflective of the patients clinicians are seeing in everyday practice. The study is a single-arm pre-post longitudinal patient-survey study and outcomes were assessed based on changes from baseline. In an interim analysis of 76 participants, mean PHQ-9 scores decreased from 15.7 at baseline to 7.1 at week 6 (model-estimated change, -9.29; 95% CI, -11.13 to -7.45; p<0.001). 76.3% of patients reached minimal/mild depression severity, defined as a PHQ-9 score ≤9, by week 6. Mean FAST scores decreased from 37.4 at baseline to 19.9 at week 6 (model-estimated change -15.86; 95% CI, -22.53 to -9.18; p<0.001). Significant improvements were also observed on the Snaith-Hamilton Pleasure Scale (SHAPS) and Motivation and Energy Inventory-Short Form (MEI-SF) by week 2 and continued through week 6.

VRAYLAR (cariprazine) US Uses and Important Safety Information

VRAYLAR is a prescription medicine used:

• along with antidepressant medicines to treat major depressive disorder (MDD) in adults
• to treat depressive episodes that happen with bipolar I disorder (bipolar depression) in adults
• to treat short-term (acute) manic or mixed episodes that happen with bipolar I disorder in adults and children ages 10 years and older
• to treat schizophrenia in adults and children ages 13 years and older

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about VRAYLAR?

Elderly people with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) taking medicines like VRAYLAR are at an increased risk of death. VRAYLAR is not approved for treating patients with dementia-related psychosis.

VRAYLAR and antidepressants increase the risk of suicidal thoughts or actions in people 24 years of age and younger especially within the first few months of treatment or when the dose is changed. Depression and other mental illnesses are the most important causes of suicidal thoughts and actions. Patients on antidepressants and their families or caregivers should watch for new or worsening depression symptoms, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when VRAYLAR or the antidepressant is started or when the dose is changed. Report any change in these symptoms immediately to the doctor.

VRAYLAR may cause serious side effects, including:

• Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death
• Neuroleptic malignant syndrome (NMS): Call your healthcare provider or go to the nearest hospital emergency room right away if you have high fever, stiff muscles, confusion, increased sweating, or changes in breathing, heart rate, and blood pressure. These can be symptoms of a rare but potentially fatal side effect called NMS. VRAYLAR should be stopped if you have NMS.
• Uncontrolled body movements (tardive dyskinesia or TD): VRAYLAR may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop taking VRAYLAR. Tardive dyskinesia may also start after you stop taking VRAYLAR.
• Late-occurring side effects: VRAYLAR stays in your body for a long time. Some side effects may not happen right away and can start a few weeks after starting VRAYLAR, or if your dose increases. Your healthcare provider should monitor you for side effects for several weeks after starting or increasing dose of VRAYLAR.
• Problems with your metabolism, such as:
  • High blood sugar and diabetes: Increases in blood sugar can happen in some people who take VRAYLAR. Extremely high blood sugar can lead to coma or death. Your healthcare provider should check your blood sugar before or soon after starting VRAYLAR and regularly during treatment. Tell your healthcare provider if you have symptoms such as feeling very thirsty, very hungry, or sick to your stomach, urinating more than usual, feeling weak, tired, confused, or your breath smells fruity.
  • Increased fat levels (cholesterol and triglycerides) in your blood: Your healthcare provider should check fat levels in your blood before or soon after starting VRAYLAR and during treatment.
  • Weight gain: Weight gain has been reported with VRAYLAR. You and your healthcare provider should check your weight before and regularly during treatment.
• Low white blood cell count: Low white blood cell counts have been reported with antipsychotic drugs, including VRAYLAR. This may increase your risk of infection. Very low white blood cell counts, which can be fatal, have been reported with other antipsychotics. Your healthcare provider may do blood tests during the first few months of treatment with VRAYLAR.
• Decreased blood pressure (orthostatic hypotension): You may feel lightheaded or faint when you rise too quickly from a sitting or lying position.
• Falls: VRAYLAR may make you sleepy or dizzy, may cause a decrease in blood pressure when changing position (orthostatic hypotension), and can slow thinking and motor skills, which may lead to falls that can cause fractures or other injuries.
• Seizures (convulsions)
• Sleepiness, drowsiness, feeling tired, difficulty thinking and doing normal activities: Do NOT drive, operate machinery, or do other dangerous activities until you know how VRAYLAR affects you. VRAYLAR may make you drowsy.
• Increased body temperature: Do not become too hot or dehydrated during VRAYLAR treatment. Do not exercise too much. In hot weather, stay inside in a cool place if possible. Stay out of the sun. Do not wear too much clothing or heavy clothing. Drink plenty of water.
• Difficulty swallowing that can cause food or liquid to get into your lungs

Who should not take VRAYLAR?
Do not take VRAYLAR if you are allergic to any of its ingredients. Get emergency medical help if you are having an allergic reaction (eg, rash, itching, hives, swelling of the tongue, lip, face or throat).

What should I tell my healthcare provider before taking VRAYLAR?
Tell your healthcare provider about any medical conditions and if you:

• have or had heart problems or a stroke
• have or had low or high blood pressure
• have or had diabetes or high blood sugar in you or your family
• have or had high levels of total cholesterol, LDL-cholesterol, or triglycerides; or low levels of HDL-cholesterol
• have or had seizures (convulsions)
• have or had kidney or liver problems
• have or had low white blood cell count
• are pregnant or plan to become pregnant. VRAYLAR may harm your unborn baby. Taking VRAYLAR during your third trimester of pregnancy may cause your baby to have abnormal muscle movements or withdrawal symptoms after birth. Talk to your healthcare provider about the risk to your unborn baby if you take VRAYLAR during pregnancy. There is a pregnancy exposure registry for women who are exposed to VRAYLAR during pregnancy. If you become pregnant or think you are pregnant during treatment, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or http://www.womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.
• are breastfeeding or plan to breastfeed. It is not known if VRAYLAR passes into breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with VRAYLAR.

Tell your healthcare provider about all medicines that you take, including prescriptions, over-the-counter medicines, vitamins, and supplements. VRAYLAR may affect the way other medicines work, and other medicines may affect how VRAYLAR works. Do not start or stop any medicines while taking VRAYLAR without talking to your healthcare provider.

What are the most common side effects of VRAYLAR?

• The most common side effects include difficulty moving or slow movements, tremors, uncontrolled body movements, restlessness and feeling like you need to move around, sleepiness, nausea, vomiting, indigestion, constipation, feeling tired, trouble sleeping, increased appetite, and dizziness.

These are not all the possible side effects of VRAYLAR.

VRAYLAR is available in 0.5 mg, 0.75 mg, 1.5 mg, 3 mg, 4.5 mg, and 6 mg capsules.

Please see the full Prescribing Information, including Boxed Warnings, and Medication Guide.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/PatientAccessSupport to learn more.

About AbbVie in Neuroscience

At AbbVie, we believe people and their care partners living with difficult-to-treat nervous system disorders deserve more, and that purpose fuels our relentless drive to discover breakthrough science and deliver innovative medicines. We are helping to shape the future of neuroscience with a diverse portfolio of approved and investigational treatments designed to address some of the greatest burdens and unmet needs across psychiatry, migraine and pain, movement disorders and neurodegeneration. Our neuroscience therapies are making a meaningful impact for people around the world today, and our continued research reflects our commitment to exploring new approaches that have the potential to advance standards of care and create possibilities for patients living with these challenging conditions. Discover more at https://www.abbvie.com/science/areas-of-focus/neuroscience.html. 

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Forward-Looking Statements 

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

US-VRAA-260413 

SOURCE AbbVie