— Fifteen abstracts underscore AbbVie’s commitment to people living with migraine
— AbbVie to present late-breaking data from the Chronic Migraine Epidemiology and Outcomes – International (CaMEO-I) study on neck pain with headache in people along with and without migraine
— Results from the particular PROGRESS Phase 3 trial on atogepant for the preventive treatment of chronic migraine within Europe will also be presented

NORTH CHICAGO, Ill. , Dec. 6, 2022 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced that information from its robust migraine portfolio will be presented at the 16 th European Headache Federation Congress 2022 (EHC 2022) taking place in Vienna, Austria , December 7-10 . A total of 15 abstracts will cover a wide range of studies across AbbVie’s migraine portfolio, including data on onabotulinumtoxinA and atogepant.

“AbbVie is a committed leader in headache with extensive history of migraine research. We work alongside patients, care partners plus clinicians in order to provide solutions for the often-unrelenting burden of headache, ” said  Mudra Kapoor,   M. D., vice president, neuroscience, global medical affairs, AbbVie. “Our research presented at this year’s EHC 2022 reinforces our commitment to making an impact within the migraine community and builds upon our mission to provide therapies for people coping with migraine. ”

At the particular meeting, researchers will present late-breaking data from the Persistent Migraine Epidemiology and Results – International (CaMEO-I) research, evaluating the frequency plus burden of neck pain with headache among people with and without having migraine.

AbbVie will also present the Stage 3 PROGRESS trial, which includes results from patients with persistent migraine living in Europe . In addition to the data presented, AbbVie will certainly host the Medical Symposium on Friday, December 9 from 2: 15-3: fifteen p. m. Central European Time (CET) titled “A Paradigm Shift in Migraine Management. inch

AbbVie abstracts presented in the EHC 2022 are outlined below.  

Key AbbVie Abstracts at EHC 2022

Abstract Title  

Abstract Details & Time Zone:
Central European Time (CET) 
 

Atogepant  

Atogepant for the particular Preventive Treatment of Chronic Migraine in Europe:
Results through the IMPROVEMENT Study

Fri, December nine

sixteen: 15 – 16: 20 pm CET 

ePoster  

Atogepant with regard to the Preventive Treatment associated with Chronic Headache: Comes from
the PROGRESS Phase 3 Trial

Friday, December 9

15: 30 – 15: 35 pm CET 

ePoster  

Sustained Response to Atogepant in Individuals with Episodic Migraine: Post
Hoc Analyses of 12- and 52-Week Phase a few Trials

Fri, December nine

fifteen: 40 – 15: 45 pm CET 

ePoster  

Monthly Headache Days, Acute Medication Use Days, and Migraine-Specific
Quality of Life inside Responders to Atogepant: A Post Hoc Analysis

Friday, December 9

16: 55 – 17: 00 pm CET 

ePoster  

Subsequent Response to Atogepant in Individuals with Episodic Migraine
after an Initial Inadequate Response: Post Hoc Analysis of a 12-week
Phase 3 Trial

Friday, Dec 9

16: 05 – sixteen: 10 pm CET 

ePoster  

Post-hoc Analysis Evaluating Safety associated with Atogepant inside ADVANCE & Open-Label
Extension Participants with Cardiovascular Risk Factors

Friday, December 9

15: forty five – 15: 50 evening CET 

ePoster    

Effect of Atogepant on the Activity Impairment in Migraine–Diary plus
Work Productivity and Activity Impairment Questionnaire in a 12-Week,
Double-blind, Randomized, Phase three or more (PROGRESS) Test for Preventive
Treatment of Chronic Migraine 

Friday, Dec 9

16: 05 – 16: 10 pm hours CET 

ePoster  

Therapy Responder Rates of Oral Atogepant for that Preventive
Treatment associated with Chronic Headache: Results from the PROGRESS Trial 

Friday, December 9

16: 40 – sixteen: 45 pm CET 

ePoster

Effect of Atogepant on Migraine-Specific Quality of Life Questionnaire and
Headache Impact Test-6 in a 12-week, Double-blind, Randomized,
Stage 3 (PROGRESS) Trial regarding Preventive Remedying of Chronic Migraine (CM)

Fri, December nine

16: 00 – 16: 05 pm CET 

ePoster  

Safety plus Tolerability of Atogepant: The Post Hoc Analysis associated with
Pooled Data from Four Clinical Trials

Friday, December 9

fifteen: 55 – 16: 00 pm CET 

ePoster  

Headache Disease

 

Characterizing Neck Pain with Head ache in People with and without Migraine:
Comes from the Persistent Migraine Epidemiology and Final results – Worldwide
(CaMEO-I) Study

 

Friday, Dec 9

15: thirty-five – 15: 40 evening CET 

Late-Breaker ePoster  

Characterizing Gaps in Precautionary Treatment of Migraine: Global Results from
the CaMEO-International Study

Fri, December nine

fifteen: 50 – 15: 55 pm CET 

ePoster  

Chronic Headache Epidemiology plus Outcomes – International (CaMEO-I) Study:
Methods and Global Findings for Diagnosis Rates plus Care

Friday, December 9

sixteen: 45 – 16: 50 pm CET 

ePoster  

OnabotulinumtoxinA  

 

Evaluation of PREEMPT Fixed-dose, Fixed-site and Follow the Discomfort
Treatment Paradigms in the PREDICT Study

Friday, December 9

15: 30 – 15: 35 pm hours CET 

ePoster  

Real-World Persistence and Costs Among Patients along with Chronic Migraine
Treated with OnabotulinumtoxinA or CGRP mAbs: A Retrospective Claims
Analysis Research

Friday, Dec 9

16: 25 – 16: 30 pm CET 

ePoster  

The EHC 2022 will become a hybrid meeting taking place in-person plus virtually. The full program for your congress can be found here .

About Atogepant
Atogepant is an orally administered, CGRP receptor antagonist (gepant) specifically developed for the precautionary remedying of headache. CGRP and its receptors are expressed in regions of the nervous system associated with migraine pathophysiology. Studies have shown that CGRP levels are elevated during migraine attacks plus selective CGRP receptor antagonists confer clinical benefit within migraine. AbbVie has submitted a marketing authorization application to the Western Medicines Agency for atogepant for that prophylaxis of headache in adult patients who have at least four migraine days per month. The use of atogepant in migraine is not approved inside the United Kingdom or European Union and its safety and efficacy possess not been evaluated.

U. S. Indications plus Important Safety Information about QULIPTA™ (atogepant)

QULIPTA is a prescription medicine used for the preventive treatment associated with episodic headache in adults.

IMPORTANT SAFETY INFORMATION

Before taking QULIPTA TM (atogepant) tablets, tell your healthcare provider about all your medical conditions, including if you:

  • Have kidney problems or are on dialysis
  • Have liver problems
  • Are pregnant or even plan in order to become pregnant. It is not really known if QULIPTA may harm your own unborn baby
  • Are usually breastfeeding or plan to breastfeed. It is not known if QULIPTA passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking QULIPTA

Tell your healthcare supplier about all the medicines you take , including prescription and over-the-counter medicines, vitamins, plus herbal supplements. QULIPTA may affect the way other medications work, and other medicines may affect how QULIPTA works. Your healthcare service provider may need to change the dose of QULIPTA when taken with certain other medications.

The most common side effects of QULIPTA are nausea, constipation, plus tiredness. These are not all the possible side results of QULIPTA.

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 might be able to help. Visit AbbVie. com/myAbbVieAssist to learn more.

Please see full Prescribing Information .

Globally, prescribing information varies; refer in order to the individual country product label for complete information.

About BOTOX ®
BOTOX ® was first approved by the FDA in 1989 for two rare eye muscle disorders – blepharospasm and strabismus in adults. Today, BOTOX ® is FDA-approved with regard to 12 therapeutic indications, which includes chronic migraine, overactive bladder, leakage of urine (incontinence) due to overactive bladder caused by a neurologic condition in grown-ups and in pediatric patients five years associated with age plus older, cervical dystonia, adult and pediatric spasticity, and severe underarm sweating (axillary hyperhidrosis). Botulinum toxin units are not interchangeable from one product to another; doses recommended in Allergan Units are different from other botulinum toxin preparations.  

U. S. Indications and Important Safety Information about BOTOX ® (onabotulinumtoxinA)

INDICATIONS

BOTOX ® (onabotulinumtoxinA) is a prescription medication that is injected into muscles and used:

  • To treat overactive bladder symptoms such as a strong need to urinate with leaking or even wetting accidents (urge urinary incontinence), the strong need to urinate right away (urgency), plus urinating often (frequency) in adults 18 years and older when another type of medicine (anticholinergic) does not really work well enough or cannot be taken
  • To treat leakage of urine (incontinence) in adults 18 many years and old with overactive bladder due to a neurologic disease when an additional type associated with medicine (anticholinergic) does not work well enough or cannot be taken
  • In order to treat overactive bladder due to a neurologic illness in children 5 years of age and older when another kind of medicine (anticholinergic) does not work good enough or can not be taken
  • To prevent headaches in grown-ups with chronic migraine who have 15 or more days each month with headache lasting 4 or more hours each day in people 18 yrs and old
  • To treat increased muscle stiffness in people 2 years of age and older with spasticity
  • To deal with the abnormal head position and neck pain that happens along with cervical dystonia (CD) within people 16 years plus older
  • To treat certain types of eye muscle mass problems (strabismus) or abnormal spasm of the eyelids (blepharospasm) in people 12 years of age group and old

BOTOX is also shot into the skin to treat the particular symptoms of severe armpit sweating (severe primary axillary hyperhidrosis) when medicines used on the pores and skin (topical) do not work well enough that individuals 18 many years and older.

It will be not recognized whether BOTOX is safe and effective to prevent headaches in patients with headache that have 14 or fewer headache days every month (episodic migraine).

BOTOX has not been shown to help people perform task-specific functions with their upper limbs or increase movement in joints that are permanently fixed in position by stiff muscles. It is not really known whether BOTOX is usually safe and effective regarding severe sweating anywhere other than your armpits.

IMPORTANT SAFETY INFORMATION

BOTOX may cause serious side effects that can be life threatening. Get medical assist right away if you have any of these problems any kind of time (hours to weeks) after injection of BOTOX:

  • Problems swallowing, speaking, or even breathing , due in order to weakening associated with associated muscle tissue, can be severe and result in loss of life. You are at the highest risk if these problems are preexisting before injection. Swallowing problems may last for several months.
  • Spread of toxin effects. The effect of botulinum toxin might affect areas away from the injection site and cause serious symptoms, including loss of strength and all-over muscle weakness; double vision; blurred eyesight; drooping eyelids; hoarseness or change or even lack of voice; trouble saying words clearly; loss of bladder control; trouble breathing; plus trouble swallowing.

There has not been a confirmed serious case of spread of contaminant effect away from the shot site when BOTOX has been used at the recommended dose to treat chronic migraine, severe underarm sweating, blepharospasm, or strabismus.

BOTOX may cause lack of strength or general muscle weakness, vision problems, or even dizziness within hours to weeks of receiving BOTOX. If this happens, do not drive a car, operate machinery, or do other dangerous activities.

Do not receive BOTOX if you are allergic to any associated with the ingredients in BOTOX (see Medication Guide with regard to ingredients); had an allergic reaction to the other botulinum toxin product such as Myobloc ® (rimabotulinumtoxinB), Dysport ® (abobotulinumtoxinA), or Xeomin ® (incobotulinumtoxinA); have a skin infection in the planned injection site.

Do not receive BOTOX for the treatment of urinary incontinence if you   have an urinary tract contamination (UTI) or even cannot empty your urinary on your own and are not routinely catheterizing. Due in order to the risk of urinary retention (difficulty fully emptying the bladder), only patients who are usually willing and able to initiate catheterization posttreatment, if required, should be considered regarding treatment.

Patients treated for overactive bladder: In clinical trials, 36 associated with the 552 patients had to self-catheterize intended for urinary retention following treatment with BOTOX compared to 2 of the 542 treated with placebo. The median duration of postinjection catheterization to get these individuals treated along with BOTOX 100 Units (n = 36) was 63 days (minimum 1 day in order to maximum 214 days), as compared to a median duration associated with 11 days (minimum 3 days in order to maximum 18 days) pertaining to patients receiving placebo (n = 2). Patients with diabetes mellitus treated with BOTOX were more likely to develop urinary : retention than nondiabetics.

Adult sufferers treated meant for overactive bladder due to a neurologic disease:   Inside clinical tests, 30. 6% of adult patients (33/108) who were not really using clean intermittent catheterization (CIC) prior to injection required catheterization for urinary retention following treatment along with BOTOX 200 Units, as compared to 6. 7% of patients (7/104) given placebo. The particular median period of postinjection catheterization for these patients treated with BOTOX two hundred Units (n = 33) was 289 days (minimum 1 day to maximum 530 days), when compared with the median length of 358 days (minimum 2 times to optimum 379 days) for individuals receiving placebo (n = 7).

Among adult sufferers not using CIC at baseline, those with multiple sclerosis were more likely to require CIC postinjection than all those with spinal cord injury.

The dose of BOTOX is not the same as, or comparable in order to, another botulinum toxin product.

Serious and/or immediate sensitive reactions have been reported,   which includes itching; rash; red, itchy welts; wheezing; asthma symptoms; dizziness; or even feeling faint. Get medical help right away if a person experience signs and symptoms; further shot of BOTOX should be discontinued.

Tell your doctor about all your muscle or nerve conditions, such because ALS or even Lou Gehrig’s disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk associated with serious side effects, including difficulty ingesting and difficulty breathing through typical doses of BOTOX.

Tell your doctor if you have any breathing-related problems.   Your doctor may monitor you designed for breathing problems during therapy with BOTOX for spasticity or just for detrusor overactivity associated with a neurologic condition. The particular risk of developing lung disease in patients with reduced lung function is increased in patients getting BOTOX.

Cornea problems have been reported. Cornea (surface of the eye) problems have been documented in some people receiving BOTOX for the purpose of their blepharospasm, especially within people with certain nerve disorders. BOTOX might cause the eyelids to blink less, which could lead to the particular surface associated with the eye being exposed to air more than is usual. Inform your physician if you experience any issues with your eyes while receiving BOTOX. Your doctor may deal with your eyes with drops, ointments, contact lenses, or even with an eye patch.

Bleeding behind the eye continues to be reported. Hemorrhaging behind the particular eyeball has been reported in some people getting BOTOX for their strabismus. Tell your doctor if you notice any new visual difficulties while receiving BOTOX.

Bronchitis plus upper respiratory tract infections (common colds) happen to be reported.   Bronchitis was reported more frequently in adults getting BOTOX for upper limb spasticity. Upper respiratory infections were also reported more frequently in grown-ups with former breathing-related problems with spasticity. In pediatric patients treated along with BOTOX with regard to upper arm or leg spasticity, upper respiratory system bacterial infections were documented more frequently. In pediatric individuals given BOTOX for lower limb spasticity, upper respiratory tract infections were not reported a lot more frequently compared to placebo.

Autonomic dysreflexia in sufferers treated regarding overactive urinary due in order to a neurologic disease.   Autonomic dysreflexia associated with intradetrusor injections of BOTOX could occur in patients treated intended for detrusor overactivity associated with a neurologic condition and may require prompt medical therapy. In clinical trials, the incidence of autonomic dysreflexia was greater in grownup patients treated with BOTOX 200 Units compared with placebo (1. 5% versus 0. 4%, respectively). Inform your doctor about all your own medical conditions, which includes in case you have or have had bleeding troubles; have plans to have surgery; had surgical treatment on your face; have some weakness of forehead muscles, trouble raising your eyebrows, drooping eyelids, and any other abnormal facial change; have symptoms of a good UTI plus are being treated to get urinary incontinence (symptoms associated with an UTI may include pain or burning along with urination, frequent urination, or even fever); have problems draining your bladder by yourself and are being treated pertaining to urinary incontinence; are pregnant or plan to become pregnant (it is just not known in case BOTOX can harm your unborn baby); are breastfeeding or plan to (it will be not known if BOTOX passes into breast milk).

Tell your doctor regarding all the particular medicines you take,   including prescription plus over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX with certain some other medicines may cause severe side effects. Usually do not start any brand new medicines until you have got told your doctor that a person have received BOTOX in the past.

Inform your doctor in case you received some other botulinum contaminant product in the last 4 weeks; have received injections of botulinum toxin such as Myobloc ® , Dysport ® , or even Xeomin ® inside the past (tell your own doctor exactly which item you received); have recently received an antibiotic by injection; take muscle relaxants; take a good allergy or cold medicine; take a sleep medication; take aspirin-like products or even blood thinners.

Other side effects associated with BOTOX consist of dry mouth; discomfort or pain in the injection site; tiredness; headache; neck pain; vision problems like double eyesight, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, plus dry eye; drooping eyebrows; and upper respiratory tract infection. Within adults becoming treated meant for urinary incontinence, other part effects include UTI and painful urination. In children being handled for bladder control problems, other negative effects include UTI and bacteria in the urine. Inside patients getting treated designed for urinary incontinence, another side effect includes the inability in order to empty your bladder on your own. If you have problems fully emptying your urinary on your own after receiving BOTOX, you may need to use disposable self-catheters to empty your bladder up to a few times each day till your bladder is able to begin emptying again.

For more information, refer to the Medicine Guide or talk along with your physician.

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

If you are having difficulty paying for your own medicine, AbbVie may become able to help. Check out AbbVie. com/myAbbVieAssist to learn more.

Please see BOTOX ® full Product Information , including Boxed Warning plus Medication Guide .

Globally, prescribing information varies; refer to the individual country product label just for complete info.

About AbbVie in Migraine
Impacting one billion people worldwide, migraine is a neurological disease with recurring attacks that causes pain and other disabling signs and symptoms. However, headache can be treatable. At AbbVie, we are committed to empowering people in their pursuit of migraine freedom. We advance science that enables healthcare providers in order to care for individuals impacted across the spectrum of headache. Through education and partnerships with the migraine community, we strive to help those with migraine navigate barriers to care, access effective treatments and reclaim their lives.

About AbbVie
AbbVie’s mission is usually to discover and deliver innovative medications that solve serious health issues today and address the particular medical challenges of tomorrow. We strive to have the remarkable impact on people’s lives throughout several key therapeutic places: immunology, oncology, neuroscience, attention care, virology, women’s health and gastroenterology, in addition to products plus services across its Allergan Aesthetics portfolio. For a lot more information about AbbVie, please visit us at  www.abbvie.com . Follow @AbbVie on  Twitter ,   Facebook ,   Instagram ,   YouTube   and  LinkedIn .

Forward-Looking Statements
Some statements in this particular news release are, or may end up being considered, forward-looking statements for the purpose of purposes of the Private Securities Litigation Reform Act of 1995. The words “believe, ” “expect, ” “anticipate, ” “project” and similar expressions, among others, generally identify forward-looking claims. AbbVie cautions that these types of forward-looking statements are subject to risks and uncertainties that might cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties consist of, but are usually not limited to, failure to realize the expected benefits through AbbVie’s acquisition of Allergan plc (“Allergan”), failure in order to promptly plus effectively integrate Allergan’s businesses, competition from other products, difficulties to intellectual property, difficulties inherent within the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact associated with public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and additional factors that may affect AbbVie’s operations is set forth in Item 1A, “Risk Factors, ” of AbbVie’s 2021 Annual Report on Form 10-K, which has already been filed along with the Investments and Exchange Commission, since updated simply by its subsequent Quarterly Reports on Type 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result associated with subsequent events or developments, except while required by law.

SOURCE AbbVie

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