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“Many individuals dwelling with main depressive dysfunction battle to discover a remedy that reduces their depressive signs, with many taking years to seek out the suitable remedy. Cariprazine, when added to ongoing antidepressant remedy in sufferers with main depressive dysfunction, demonstrated that it may cut back depressive signs,” mentioned Michael Severino , M.D., vice chairman and president, AbbVie. “We look ahead to working carefully with the FDA throughout the assessment of our submission to carry a possible new adjunctive remedy to sufferers with main depressive dysfunction who’re taking an antidepressant and looking for extra aid. This submission demonstrates our robust dedication to addressing extra gaps within the care of individuals affected by psychiatric problems.”

Cariprazine is marketed as VRAYLAR® in the US and is FDA-approved to deal with adults with depressive, acute manic and blended episodes related to bipolar I dysfunction, in addition to schizophrenia. Cariprazine is being co-developed by AbbVie and Gedeon Richter Plc. Greater than 8,000 sufferers worldwide have been handled with cariprazine throughout greater than 20 medical trials evaluating the efficacy and security of cariprazine for a broad vary of psychiatric problems.

About Main Depressive Dysfunction (MDD)
MDD is without doubt one of the commonest psychological problems in the US . In 2020, an estimated 21 million adults had at the very least one main depressive episode. For some people, MDD may end up in extreme impairment which can intrude with or restrict one’s day by day actions. ¹ The World Well being Group lists melancholy because the third-leading reason behind incapacity worldwide and as a serious contributor to the general world burden of illness. Signs can embrace depressed temper, lack of pleasure or curiosity in actions, modifications in urge for food or weight, modifications in sleep, psychomotor retardation, lack of vitality, emotions of worthlessness, indecisiveness, and recurrent ideas of loss of life. ² In the US , the estimated financial burden of MDD has been estimated to be round $326 billion . ³

About Examine 3111-301-001
Examine 3111-301-001 is a randomized, double-blind, placebo-controlled, multicenter trial with 759 contributors performed in United States , Bulgaria , Estonia , Germany , Hungary , Ukraine and the United Kingdom . Following a screening interval of as much as 14 days, sufferers with an insufficient medical response to their antidepressant monotherapy (ADT) had been randomized into three remedy teams (1:1:1). The primary group obtained cariprazine 1.5 mg/day + ADT, the second group obtained cariprazine 3.0 mg/day + ADT, and the third group obtained placebo + ADT. For six weeks, the remedy was given as soon as day by day along with the continued ADT remedy. Preliminary examine findings had been introduced on October 29 ^th , 2021 and shall be introduced at a future medical assembly.

About Examine RGH-MD-75
Examine RGH-MD-75 is a randomized, double-blind, placebo-controlled, flexible-dose, outpatient, multicenter trial with 808 contributors, performed in United States , Estonia , Finland , Slovakia , Ukraine and Sweden . After 7-14 days of screening and washout of prohibited medicines, eligible sufferers entered an 8-week, double-blind remedy interval through which they continued antidepressant remedy and had been randomized (1:1:1) to adjunctive cariprazine 1-2 mg/day, cariprazine 2-4.5 mg/day, or placebo. Information from Examine RGH-MD-75 had been printed within the Journal of Scientific Psychiatry . ⁴

About Examine RGH-MD-76
Examine RGH-MD-76 is a long-term, multi-center, open label, flexible-dose security and tolerability examine with 347 contributors, performed in the US . The examine had one remedy group that obtained caripriazine 1.5-4.5 mg/d + ADT for 26 weeks. Sufferers coming into from the 8-week lead-in examine continued ADT at their lead-in examine dose; new sufferers continued their protocol-allowed ADT. On day 1, cariprazine was initiated at 0.5 mg/day; the dosage was elevated by 0.5 mg/day till the goal dose of three.0 mg/day was obtained on days 6 and seven. Dosages could possibly be decreased to 1.5 mg/day for tolerability causes at any time starting at week 1 or elevated to 4.5 mg/day for insufficient response between weeks 2 and 10. Information from Examine RGH-MD-76 had been printed in Worldwide Scientific Psychopharmacology . ⁵

Extra data will be discovered on www.clinicaltrials.gov (NCT03738215, NCT01469377, NCT01838876).

About VRAYLAR ^® (cariprazine)
VRAYLAR is an oral, once-daily atypical antipsychotic permitted for the acute remedy of adults with manic or blended episodes related to bipolar I dysfunction (3 to six mg/day) and for the remedy of depressive episodes related to bipolar I dysfunction (bipolar melancholy) in adults (1.5 or 3 mg/day). VRAYLAR can also be permitted for the remedy of schizophrenia in adults (1.5 to six mg/day). Use of VRAYLAR in adjunctive remedy of main depressive dysfunction is just not permitted and its security and efficacy haven’t been evaluated by regulatory authorities.

Whereas the mechanism of motion of VRAYLAR is unknown, the efficacy of VRAYLAR could possibly be mediated via a mix of partial agonist exercise at central dopamine D₂ and serotonin 5-HT _1A receptors and antagonist exercise at serotonin 5-HT _2A receptors. Pharmacodynamic research with VRAYLAR have proven that it might act as a partial agonist with excessive binding affinity at dopamine D ₃ , dopamine D ₂ , and serotonin 5-HT _1A receptors. VRAYLAR demonstrated as much as ~8-fold better in vitro affinity for dopamine D ₃ vs D ₂ receptors. VRAYLAR additionally acts as an antagonist at serotonin 5-HT _2B and 5-HT _2A receptors with excessive and reasonable binding affinity, respectively in addition to it binds to the histamine H ₁ receptors. VRAYLAR exhibits decrease binding affinity to the serotonin 5-HT _2C and α _1A – adrenergic receptors and has no considerable affinity for cholinergic muscarinic receptors. ⁶ The medical significance of those in vitro knowledge is unknown.

VRAYLAR is being developed collectively by AbbVie and Gedeon Richter Plc, with AbbVie answerable for commercialization within the U.S., Canada, Japan , Taiwan and sure Latin American nations (together with Argentina , Bolivia , Brazil , Chile , Colombia , Ecuador , Mexico , Peru and Venezuela ).

VRAYLAR ^® (cariprazine) Makes use of and Vital Security Info

VRAYLAR is a prescription medication utilized in adults:

• to deal with schizophrenia
• for short-term (acute) remedy of manic or blended episodes that occur with bipolar I dysfunction
• to deal with depressive episodes that occur with bipolar I dysfunction (bipolar melancholy)

What is the most necessary data I ought to know about VRAYLAR?

Aged individuals with dementia-related psychosis (having misplaced contact with actuality as a consequence of confusion and reminiscence loss) taking medicines like VRAYLAR are at an elevated threat of loss of life. VRAYLAR is just not permitted for treating sufferers with dementia-related psychosis.

Antidepressants might enhance suicidal ideas or actions in some youngsters and younger adults throughout the first few months of remedy and when the dose is modified. Melancholy and different severe psychological sicknesses are an important causes of suicidal ideas and actions. Sufferers on antidepressants and their households or caregivers ought to watch for brand new or worsening melancholy signs, particularly sudden modifications in temper, behaviors, ideas, or emotions. This is essential when an antidepressant is began or when the dose is modified. Report any change in these signs instantly to the physician.

V RAYLAR might trigger severe aspect results, together with:

• S troke (cerebrovascular issues) in aged individuals with dementia-related psychosis that may result in loss of life
• N eu r o l ep tic malignant syndrome (NMS): Name your healthcare supplier or go to the closest hospital emergency room straight away if in case you have excessive fever, stiff muscle tissues, confusion, elevated sweating, or modifications in respiratory, coronary heart charge, and blood stress. These will be signs of a uncommon however probably deadly aspect impact referred to as NMS. VRAYLAR must be stopped if in case you have NMS
• Uncontrolled physique actions (t a r di v e dyskinesia or TD): VRAYLAR might trigger actions that you just can’t management in your face, tongue, or different physique components. Tardive dyskinesia might not go away, even when you cease taking VRAYLAR. Tardive dyskinesia can also begin after you cease taking VRAYLAR
• Late-occurring unwanted effects: VRAYLAR stays in your physique for a very long time. Some unwanted effects might not occur straight away and may begin just a few weeks after beginning VRAYLAR, or in case your dose will increase. Your healthcare supplier ought to monitor you for unwanted effects for a number of weeks after beginning or rising dose of VRAYLAR
• Issues together with your metabolism, similar to:
• Excessive blood sugar and diabetes: Will increase in blood sugar can occur in some individuals who take VRAYLAR. Extraordinarily excessive blood sugar can result in coma or loss of life. Your healthcare supplier ought to test your blood sugar earlier than or quickly after beginning VRAYLAR and repeatedly throughout remedy. Inform your healthcare supplier if in case you have signs similar to feeling very thirsty, very hungry, or sick to your abdomen, urinating greater than standard, feeling weak, drained, confused, or your breath smells fruity
• I n cr ea sed fats ranges (ldl cholesterol and triglycerides) in your blood: Your healthcare supplier ought to test fats ranges in your blood earlier than or quickly after beginning VRAYLAR and through remedy
• Wei g h t acquire: Weight acquire has been reported with VRAYLAR. You and your healthcare supplier ought to test your weight earlier than and repeatedly throughout remedy
• Low white blood cell depend: Low white blood cell counts have been reported with antipsychotic medication, together with VRAYLAR. This will enhance your threat of an infection. Very low white blood cell counts, which will be deadly, have been reported with different antipsychotics. Your healthcare supplier might do blood assessments throughout the first few months of remedy with VRAYLAR
• Decreased blood stress (orthostatic hypotension): Chances are you’ll really feel lightheaded or faint while you rise too rapidly from a sitting or mendacity place
• Falls: VRAYLAR might make you sleepy or dizzy, might trigger a lower in blood stress when altering place (orthostatic hypotension), and may sluggish pondering and motor expertise, which can result in falls that may trigger fractures or different accidents
• Se iz u r e s (convulsions)
• I mpaired judgment, pondering, and motor expertise: Do NOT drive, function equipment, or do different harmful actions till you understand how VRAYLAR impacts you. VRAYLAR might make you drowsy
• Elevated physique temperature: Don’t change into too scorching or dehydrated throughout VRAYLAR remedy. Don’t train an excessive amount of. In scorching climate, keep inside in a cool place if attainable. Keep out of the solar. Don’t put on an excessive amount of clothes or heavy clothes. Drink loads of water
• Problem swallowing that may trigger meals or liquid to get into your lungs

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

What ought to I inform my healthcare supplier earlier than taking VRAYLAR?

Inform your healthcare supplier about any medical circumstances and if you:

• have or have had coronary heart issues or a stroke
• have or have had low or hypertension
• have or have had diabetes or excessive blood sugar in you or your loved ones
• have or have had excessive ranges of complete ldl cholesterol, LDL-cholesterol, or triglycerides; or low ranges of HDL-cholesterol
• have or have had seizures (convulsions)
• have or have had kidney or liver issues
• have or have had low white blood cell depend
• are pregnant or plan to change into pregnant. VRAYLAR might hurt your unborn child. Speak to your healthcare supplier concerning the threat to your unborn child when you take VRAYLAR throughout being pregnant. Should you change into pregnant or assume you’re pregnant throughout remedy, speak to your healthcare supplier about registering with the Nationwide Being pregnant 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 isn’t recognized if VRAYLAR passes into breast milk. Speak to your healthcare supplier about the easiest way to feed your child throughout remedy with VRAYLAR

Inform your healthcare supplier about all medicines that you take, together with prescriptions, over-the-counter medicines, nutritional vitamins, and dietary supplements. VRAYLAR might have an effect on the manner different medicines work, and different medicines might have an effect on how VRAYLAR works. Don’t begin or cease any medicines whereas taking VRAYLAR with out speaking to your healthcare supplier.

What are the most frequent aspect results of VRAYLAR?

• The most frequent aspect results had been problem shifting or sluggish actions, tremors, uncontrolled physique actions, restlessness and feeling like you must transfer round, sleepiness, nausea, vomiting, and indigestion.

These are not all attainable aspect results of VRAYLAR.

You might be inspired to report unfavourable unwanted effects of pharmaceuticals to the FDA. Go to www.fda.gov/medwatch or name 1-800-FDA-1088.

If you’re having problem paying in your medication, AbbVie could possibly assist. Go to AbbVie.com/myAbbVieAssist to study extra.

Please see the complete Prescribing Info , together with Boxed Warnings, and Medicine Information .

Globally, prescribing data varies; discuss with the person nation product label for full data.

About AbbVie in Psychological Well being
AbbVie is driving the pursuit of higher psychological well being. During the last 30 years, the corporate’s scientists and clinicians have labored to deal with the complexity of psychological sickness and immediately provide a portfolio of medicines and a pipeline of innovation that spans melancholy, nervousness, bipolar I dysfunction, and schizophrenia. To study extra about AbbVie’s work to assist people all through their psychological well being journey, please go to www.abbvie. com or comply with @abbvie on Twitter , Fb , Instagram , YouTube and LinkedIn .

About AbbVie
AbbVie’s mission is to find and ship revolutionary medicines that remedy severe well being points immediately and handle the medical challenges of tomorrow. We attempt to have a exceptional influence on individuals’s lives throughout a number of key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, girls’s well being and gastroenterology, along with services throughout its Allergan Aesthetics portfolio. For extra details about AbbVie, please go to us at www.abbvie.com . Comply with @abbvie on Twitter , Fb , Instagram , YouTube and LinkedIn .

Ahead-Wanting Statements
Some statements on this information launch are, or could also be thought-about, forward-looking statements for functions of the Non-public Securities Litigation Reform Act of 1995. The phrases “imagine,” “count on,” “anticipate,” “venture” and comparable expressions, amongst others, usually determine forward-looking statements. AbbVie cautions that these forward-looking statements are topic to dangers and uncertainties which will trigger precise outcomes to vary materially from these indicated within the forward-looking statements. Such dangers and uncertainties embrace, however will not be restricted to, failure to appreciate the anticipated advantages from AbbVie’s acquisition of Allergan plc (“Allergan”), failure to promptly and successfully combine Allergan’s companies, competitors from different merchandise, challenges to mental property, difficulties inherent within the analysis and growth course of, hostile litigation or authorities motion, modifications to legal guidelines and laws relevant to our business and the influence of public well being outbreaks, epidemics or pandemics, similar to COVID-19. Extra details about the financial, aggressive, governmental, technological and different components which will have an effect on AbbVie’s operations is about forth in Merchandise 1A, “Threat Elements,” of AbbVie’s 2021 Annual Report on Kind 10-Okay, which has been filed with the Securities and Change Fee, as up to date by its subsequent Quarterly Stories on Kind 10-Q. AbbVie undertakes no obligation to launch publicly any revisions to forward-looking statements on account of subsequent occasions or developments, besides as required by regulation.

References:

1. Substance Abuse and Psychological Well being Providers Administration. Key substance use and psychological well being indicators in the US : Outcomes from the 2020 Nationwide Survey on Drug Use and Well being. Heart for Behavioral Well being Statistics and High quality. 2021. https://www.samhsa.gov/knowledge/ . Accessed February 1, 2022 .
2. World Well being Group. Melancholy. Truth Sheet. 2021. Obtainable at: https://www.who.int/news-room/fact-sheets/element/melancholy . Accessed February 1, 2022 .
3. Greenberg P, Fournier AA, Sistsky T, et al. Pharmacoeconomics. 2021;39(6):653-65.
4. Durgam S, Earley W, Guo H, et al. Efficacy and security of adjunctive cariprazine in insufficient responders to antidepressants: a randomized, double-blind, placebo-controlled examine in grownup sufferers with main depressive dysfunction. J Clin Psychiatry. 2016;77(3):371-8. doi: 10.4088/JCP.15m10070.
5. Vieta E, Earley W, Burgess M, et al. Lengthy-term security and tolerability of cariprazine as adjunctive remedy in main depressive dysfunction. Worldwide Scientific Psychopharmacology. 2019;34(2)76-83. doi: 10.1097/YIC.0000000000000246
6. AbbVie. VRAYLAR (cariprazine) [package insert]. U.S. Meals and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204370s006lbl.pdf . Revised January 2019 . Accessed February 15, 2022 .

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SOURCE AbbVie