–  Approval marks fourth indication for VRAYLAR, backed by proven efficacy and well-established tolerability as an adjunctive treatment for major depressive disorder (MDD) with an antidepressant therapy (ADT), showing improvement in symptoms when compared to placebo + ADT

–  Designed with regard to specific mood disorders, VRAYLAR is now the first and only dopamine plus serotonin partial agonist FDA-approved for the particular most common forms of depression – being an adjunctive therapy for MDD and the treatment of depressive episodes associated with bipolar I problem

–  About one in five U. S. adults will experience MDD during their lifetime, and many of them may have partial response to the treatment with a good ADT

NORTH CHICAGO, Ill. , Dec. 16, 2022 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced that the particular U. H. Food plus Drug Administration (FDA) has approved VRAYLAR ® (cariprazine) as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults. Supported by clinical data demonstrating efficacy and well-established tolerability, this additional indication provides a new option regarding adults who have a partial response to the treatment of an antidepressant.

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“Many living with main depressive condition find that their own ongoing antidepressant therapy doesn’t offer meaningful relief from the symptoms they experience every day, ” said Thomas Hudson , M. D., senior vice president, research plus development, chief scientific officer, AbbVie. “Today’s approval associated with VRAYLAR provides an important new treatment option to meet a critical unmet medical need. AbbVie is committed to driving progress and advancing solutions intended for patients coping with complex neuropsychiatric conditions. ”

MDD is one of the most common mental disorders in the U. S.; approximately one in five adults will experience this disorder during their lifetime. 1 In a large U. T. study of adults along with MDD, around 50 percent still had depressive symptoms with their first antidepressant. 2 If some symptoms of depression persist while on an antidepressant, adding the different type of medication, often referred to as an adjunctive treatment, to the existing regimen may help.

“Patients along with inadequate reaction to standard antidepressant medication are often frustrated by the particular experience associated with trying multiple medicines and still suffering from unresolved signs and symptoms. Instead of starting over with another regular antidepressant, VRAYLAR works with a good existing therapy and can help build on the progress already made, ” said Gary Sachs , MD, medical vice chief executive at Signant Health, associate clinical professor of psychiatry at Massachusetts General Hospital, and lead Phase 3 clinical trial investigator. “For adults living with major depressive disorder, because of inadequate enhancement in response to standard antidepressants, VRAYLAR is an efficacious adjunctive treatment option with a well-characterized safety profile. inch

Cariprazine is marketed as VRAYLAR ® within the Oughout. S., and in addition to being approved as an adjunctive therapy to antidepressants for the particular remedying of MDD in grown-ups, it is FDA-approved to treat adults along with depressive, acute manic plus mixed episodes associated with zweipolig I problem, as well as schizophrenia. Cariprazine is co-developed by AbbVie and Gedeon Richter Plc. More than 8, 000 patients worldwide have been treated with cariprazine across more than 20 clinical trials evaluating the efficacy plus safety of cariprazine to get a broad range associated with psychiatric problems.

“When we were in the early stages of development for cariprazine, we focused on designing a compound that covers a range of symptoms for mental health conditions and affects the dopamine D3 receptor, ” stated István Greiner, Ph. D., research and development, director, Gedeon Kadi (umgangssprachlich) . “While schizophrenia and bipolar manic and mixed episodes were the first indications within the You. S. market, we are thrilled to see the full potential of cariprazine unlocked with approvals in bipolar I depressive disorders, and now, as an antidepressant adjunct in major depressive disorder. ”

Highlights from the particular clinical program supporting the approval include:

  • A Phase 3 Study 3111-301-001 showed a clinically and statistically significant change from baseline to week six in the Montgomery -Åsberg Depression Rating Scale (MADRS) total score pertaining to patients treated with cariprazine at 1. 5 mg/day + ADT compared with placebo + ADT. A second registration-enabling study, RGH-MD-75, demonstrated a medically and statistically significant change from baseline in order to week eight in the particular MADRS overall score meant for patients treated with cariprazine at 2-4. 5 mg/day (mean dose 2. 6 mg) + ADT in contrast to placebo + ADT.
  • Cariprazine was generally well tolerated in 6- and 8-week studies. Mean weight change was < 2lbs plus ≤ 3% of individuals had a weight increase of ≥ 7%.
  • The starting dosage of VRAYLAR is one. 5 mg once daily. Depending upon scientific response and tolerability, the dosage can be increased to a few mg once daily upon Day 15. In clinical trials, dose titration in intervals associated with less than 14 days resulted in a higher incidence of adverse reactions. The maximum recommended dosage is 3 magnesium once every day.  
  • Most common adverse reactions observed within the adjunctive MDD studies (≥ 5% and at least twice the particular rate associated with placebo) had been:
    • Akathisia, nausea, plus insomnia at the recommended doses in 6-week, fixed-dose tests
    • Akathisia, restlessness, fatigue, constipation, nausea, improved appetite, dizziness, insomnia, and extrapyramidal signs and symptoms in 1 8-week flexible-dose trial from a titration of less than 14 days

About Major Depressive Disorder (MDD)
MDD will be one of the most typical mental disorders in  the U. S i9000., characterized simply by symptoms such as overwhelming feelings associated with sadness and/or loss of interest that don’t go away after two weeks. 3 MDD may cause severe functional impairment, adversely affect interpersonal relationships, and may impact the particular quality associated with life. 4 It is the leading cause of disability in the world, 5 and has a lifetime prevalence of 20% designed for adults within the U. Ersus. 1 Symptoms can include depressed feeling, loss associated with pleasure or interest in activities, feelings of worthlessness, lack of energy, poor concentration, appetite changes, sleep disturbances, suicidal thoughts, plus feeling restless or moving or talking more slowly. three or more   In  the particular U. Nasiums., the estimated economic burden of MDD has been approximated to be around  $326 billion in 2020. six

About Research 3111-301-001
Study 3111-301-001 is usually a randomized, double-blind, placebo-controlled, multicenter test with 751 participants conducted in the United States , Bulgaria , Estonia , Germany , Hungary , Ukraine and the United Kingdom . Following a screening period of up to fourteen days, patients with an inadequate medical response to their antidepressant monotherapy (ADT) were randomized into three treatment groups (1: one: 1). The particular first group received cariprazine 1. five mg/day + ADT, the second group received cariprazine 3. 0 mg/day + ADT, and the particular third team received placebo + ADT. For six weeks, the medication was given once daily in inclusion to the particular ongoing ADT treatment. Patients given cariprazine 3. 0 mg/day + ADT demonstrated improvement inside MADRS total score with week 6 over placebo + ADT but did not meet statistical significance.

Regarding Study RGH-MD-75
Study RGH-MD-75 is a randomized, double-blind, placebo-controlled, flexible-dose, outpatient, multicenter trial along with 808 participants, conducted in the usa , Estonia , Finland , Slovakia , Ukraine and Sweden . After 7-14 days of screening and washout of prohibited medications, eligible patients entered an 8-week, double-blind treatment period inside which these people continued antidepressant treatment and were randomized (1: 1: 1) in order to adjunctive cariprazine 1-2 mg/day, cariprazine 2-4. 5 mg/day, or placebo. Data through Study RGH-MD-75 were published in the Journal associated with Clinical Psychiatry . 7 Individuals treated with cariprazine 1-2 mg/day + ADT demonstrated improvement in MADRS total score at 7 days eight over placebo + ADT but did not meet statistical importance.

About  VRAYLAR ®   (cariprazine)
VRAYLAR is an oral, once-daily atypical antipsychotic approved as a good adjunctive treatment to medicine for that therapy of major depressive condition (MDD) in adults (1. 5 or three or more mg/day), for your treatment of depressive shows related to zweipolig I disorder (bipolar depression) in grown-ups (1. 5 or even 3 mg/day), and for the particular acute treatment of grown ups with mania or combined episodes connected with bipolar I disorder (3 to 6 mg/day). VRAYLAR is also approved just for the treatment of schizophrenia in adults (1. 5 to 6 mg/day).

While the mechanism associated with action of VRAYLAR is definitely unknown, the efficacy associated with VRAYLAR is usually thought to be mediated through a combination of partial agonist activity on central dopamine D₂  plus serotonin 5-HT 1A   receptors and antagonist activity at serotonin 5-HT 2A   receptors. Pharmacodynamic research with VRAYLAR have shown that it might act as the partial agonist with high binding affinity at dopamine D 3 , dopamine Deb 2 , plus serotonin 5-HT 1A  receptors. VRAYLAR exhibited up to ~8-fold greater  in vitro  appreciation for dopamine D 3   vs D 2   receptors. VRAYLAR furthermore acts as an antagonist at serotonin 5-HT 2B   and 5-HT 2A   receptors with high and moderate binding affinity, respectively and also it binds in order to the histamine H 1   receptors. VRAYLAR shows lower   binding affinity to the particular serotonin 5-HT 2C   and α 1A — adrenergic receptors and it has no appreciable appreciation for cholinergic muscarinic receptors. eight   The scientific significance of these  in vitro   data will be unknown.

VRAYLAR is developed jointly by AbbVie and  Gedeon Richter Plc, along with AbbVie responsible for commercialization in the U. Ings.,   Canada,   Japan,   Taiwan  and certain Latin American countries (including Argentina , Bolivia , Brazil , Chile , Colombia , Ecuador , Mexico , Peru plus Venezuela ).

Visit www.vraylar.com for the purpose of more information.

VRAYLAR ®   (cariprazine) Uses and Important Safety Information
VRAYLAR can be a prescription medicine used in adults:  

  • to deal with schizophrenia
  • for short-term (acute) remedying of manic or blended episodes that will happen with bipolar We disorder
  • to treat depressive episodes that happen along with bipolar I actually disorder (bipolar depression)
  • along with antidepressant medicines to treat major depressive disorder

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

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

VRAYLAR and antidepressants may increase suicidal thoughts or actions in some children plus young adults especially within the 1st few months of therapy or when the dose is changed. Depression and other mental illnesses are the particular most important causes of thoughts of suicide and actions. Patients on antidepressants and their families or caregivers should watch for brand new or worsening depression symptoms, especially sudden changes in mood, behaviors, thoughts, or even feelings. This is very important when VRAYLAR or the antidepressant is certainly started or when the dosage is transformed. Report any change within these signs and symptoms immediately towards the doctor.

VRAYLAR  may  cause  serious  side  effects,   including:

  • Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that will 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, improved sweating, or even changes inside breathing, heart rate, plus blood pressure. These can be symptoms of a rare but potentially fatal side effect called NMS. VRAYLAR should become stopped in case you have got NMS.
  • Uncontrolled  body movements (tardive dyskinesia or TD):   VRAYLAR may cause movements that you cannot control in your face, tongue, or even other entire 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 negative effects might not happen right away and can begin a few weeks right after starting VRAYLAR, or when your dosage increases. Your healthcare provider should monitor you with regard to unwanted effects regarding several weeks after beginning or increasing dose of VRAYLAR.
  • Problems along with your metabolism, such as:
    • High  blood  sugar  and  diabetes:   Increases in blood sugar can happen in some people who take VRAYLAR. Extremely high bloodstream sugar can lead to coma or death. Your own healthcare supplier should check your blood sugar before or even soon after starting VRAYLAR and regularly during treatment. Tell your healthcare provider if you have symptoms like feeling very thirsty, really hungry, or sick to your stomach, urinating more compared to usual, feeling weak, tired, confused, or even your breath smells fruity.
    • Increased fat levels (cholesterol and triglycerides) in your blood: Your doctor should examine fat amounts in your blood before or soon after starting VRAYLAR plus during therapy.
    • Weight  gain:   Weight  gain continues to be reported  with  VRAYLAR. You and your healthcare  provider  should check  your  weight before  and regularly  during  treatment.
  • Low white bloodstream cell count:   Low white blood cell counts happen to be reported with antipsychotic drugs, including VRAYLAR. This may increase your risk of infection. Very low white blood cellular counts, which can be fatal, possess been reported with other antipsychotics. Your healthcare provider might do blood tests during the first few weeks of treatment with VRAYLAR.
  • Decreased blood pressure (orthostatic hypotension):   You may feel lightheaded or faint when you rise too quickly from a sitting or even lying position.
  • Falls:   VRAYLAR may make you sleepy or dizzy, could cause a decrease in blood vessels pressure whenever changing placement (orthostatic hypotension), and can slow thinking and motor skills, which usually may result in falls that can cause fractures or some other injuries.
  • Seizures (convulsions)
  • Sleepiness, drowsiness, feeling exhausted, difficulty believing and doing normal actions: Do NOT drive, operate machinery, or even do additional dangerous routines until you know how VRAYLAR affects a person. VRAYLAR may make you drowsy.
  • Increased body temperature:   Do not become too hot or dehydrated during VRAYLAR treatment. Do not exercise too much. In very hot weather, stay inside in a cool place if possible. Stay out of the particular sun. Perform not wear too much clothing or heavy clothing. Drink plenty of water.
  • Difficulty swallowing   that may cause food or liquid to get into your own lungs

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

What  should  We tell  my healthcare  provider  before  taking  VRAYLAR?
Inform your healthcare  provider  about  any  medical problems and  if  you:

  • have or even have had heart problems or a stroke
  • have or have experienced low or even high blood pressure
  • have got or have had diabetes or higher blood sugar levels within you or your family
  • have or have got high ranges of total cholesterol, LDL-cholesterol, or triglycerides; or low levels associated with HDL-cholesterol
  • possess and have acquired seizures (convulsions)
  • have or even have had kidney or liver issues
  • have or have had lower white blood cell count
  • are pregnant or plan to become expecting. VRAYLAR might harm your unborn baby. Taking VRAYLAR throughout your third trimester of pregnancy might cause your baby to have abnormal muscle motions or withdrawal symptoms right after birth. Talk to your own doctor about the danger to your developing fetus in the event that you get VRAYLAR during pregnancy. If you become expectant or think you are expecting a baby during therapy, talk to your health care provider regarding registering with the National Pregnancy Registry intended for Atypical Antipsychotics at 1-866-961-2388 or  http://www.womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/ .
  • are breastfeeding or intend to breastfeed. It is not known if VRAYLAR passes into breast milk. Talk to your healthcare service provider about the best way in order to feed your baby during treatment with VRAYLAR.

Tell your healthcare  provider  about  all  medicines  that  you  consider, including prescriptions,   over-the-counter  medicines,   vitamins, and  supplements. VRAYLAR  may  affect  the  way  other medications work,   and  other  medicines  may  affect  how VRAYLAR  works. Do not start or even stop any kind of medicines while taking VRAYLAR without speaking to your own healthcare company.

What  are  the  most  common  side  effects  of VRAYLAR?

  • The  most  common  side  effects consist of difficulty shifting or slow movements, tremors, uncontrolled entire body movements, uneasyness and sensation like you need to move around, sleepiness, nausea, vomiting, indigestion, constipation, feeling tired, trouble sleeping, increased appetite, and fatigue.

These  are  not  all the possible  side  effects  of  VRAYLAR.

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

You are usually encouraged to report negative side effects of prescription medicines to the FOOD AND DRUG ADMINISTRATION. Visit  www.fda.gov/medwatch   or call 1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie may end up being able in order to help. Check out AbbVie. com/myAbbVieAssist to learn more.

About AbbVie inside Mental Health
AbbVie is usually driving the particular pursuit of better mental health. Over the last 30 years, the company’s scientists plus clinicians have worked to tackle the complexity of psychological illness and today offer the portfolio associated with medicines and a pipeline of innovation that spans depression, anxiety, bipolar I actually disorder, plus schizophrenia. To learn more about AbbVie’s work to support individuals throughout their mental health journey, please visit  www.abbvie. com   or even follow @abbvie on  Twitter ,   Facebook ,   Instagram ,   YouTube   and  LinkedIn .

About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have got a remarkable impact upon people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across our Allergan Aesthetics portfolio. For more info about AbbVie, please visit us at  www.abbvie.com .

Follow  @abbvie  on  Twitter ,   Facebook ,   Instagram ,   YouTube   and  LinkedIn .

Forward-Looking Statements
A few 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, inch “expect, inches “anticipate, ” “project” plus similar expressions, among others, usually identify forward-looking statements. AbbVie cautions that will these forward-looking statements are subject in order to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking claims. Such risks and uncertainties include, but are not really limited to, failure to realize the expected benefits from AbbVie’s acquisition associated with Allergan plc (“Allergan”), failing to promptly and effectively integrate Allergan’s businesses, competition from other items, challenges to intellectual property, difficulties inherent within the research and advancement process, adverse litigation or government action, changes in order to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or even pandemics, this kind of as COVID-19. Additional details concerning the economic, competitive, governmental, technological plus other factors that might affect AbbVie’s operations is set forth in Item 1A, “Risk Factors, inch of AbbVie’s  2021  Annual Report on Form 10-K, which offers been filed with the particular Securities and Exchange Commission, as updated by its subsequent Quarterly Reports upon Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements because a result of subsequent events or developments, except as required by law.

US-VRAA-220055

References:

  1. Hasin DS, Sarvet AL, Meyers JL, et al. Epidemiology of Adult DSM-5 Major Depressive Disorder plus Its Specifiers in america . JAMA Psychiatry . 2018; 75(4): 336-346.
  2. Trivedi MH, Rush AJ, Wisniewski SR, et al. Am J Psychiatry. 2006; 163(1): 28-40.
  3. National Institute associated with Mental Wellness (2022). Depressive disorders. Available in: https://www.nimh.nih.gov/health/topics/depression . Accessed December 2022 .
  4. Bains N, Abdijadid Beds. Major Depressive Disorder. [Updated 2022 Jun 1 ]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available at: https://www.ncbi.nlm.nih.gov/books/NBK559078/ . Accessed December 2022 .
  5. Friedrich MJ. Depressive disorder Is the Leading Cause of Disability Around the World . JAMA. 2017; 317(15): 1517.
  6. Greenberg P, Fournier AA, Sistsky T, et ing.   Pharmacoeconomics.   2021; 39(6): 653-65.
  7. Durgam Ring, Earley W, Guo H, et ‘s. J Clin Psychiatry. 2016; 77(3): 371-8.
  8. VRAYLAR. Package insert. Allergan USA , Inc; 2022.

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