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

NORTH CHICAGO, Ill., Dec. 6, 2022 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced that data 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 information on onabotulinumtoxinA and atogepant.

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

At the particular meeting, researchers will present late-breaking data from the Chronic Migraine Epidemiology and Outcomes – International (CaMEO-I) study, evaluating the frequency plus burden of neck discomfort with head ache among people with minus headache.

AbbVie will also present the Stage 3 PROGRESS trial, including results through patients along with chronic migraine living in Europe. In addition to the data presented, AbbVie will host a Medical Symposium upon Friday, Dec 9 from 2: 15-3: 15 p. m. Central European Time (CET) titled “A Paradigm Shift in Migraine Management. ”

AbbVie abstracts presented in the EHC 2022 are outlined below.

Key AbbVie Abstracts at EHC 2022

Abstract Title

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

Atogepant

Atogepant for that Preventive Treatment of Persistent Migraine in Europe:
Comes from the particular PROGRESS Study

Friday, December 9

16: 15 – 16: 20 pm CET

ePoster

Atogepant for your Preventive Remedying of Chronic Migraine: Results from
the IMPROVEMENT Phase 3 Trial

Friday, December 9

15: 30 – 15: 35 pm CET

ePoster

Sustained Response to Atogepant within Individuals with Episodic Headache: Post
Hoc Analyses of 12- and 52-Week Phase three or more Trials

Fri, December nine

15: 40 – fifteen: 45 evening CET

ePoster

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

Friday, December 9

16: 55 – 17: 00 pm hours CET

ePoster

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

Friday, Dec 9

sixteen: 05 – 16: 10 pm VOTRE

ePoster

Post-hoc Analysis Evaluating Safety of Atogepant in ADVANCE & Open-Label
Extension Participants along with Cardiovascular Risk Factors

Fri, December nine

15: 45 – 15: 50 pm CET

ePoster

Effect associated with Atogepant on the Activity Impairment inside Migraine–Diary plus
Work Productivity and Activity Impairment Questionnaire in a 12-Week,
Double-blind, Randomized, Phase 3 (PROGRESS) Test for Precautionary
Take care of Chronic Migraine

Friday, December 9

16: 05 – 16: ten pm CET

ePoster

Treatment Responder Rates of Oral Atogepant to the Preventive
Treatment of Chronic Headache: Results from the PROGRESS Demo

Friday, Dec 9

sixteen: 40 – 16: forty five pm VOTRE

ePoster

Effect of Atogepant on Migraine-Specific Quality associated with Life Questionnaire and
Headache Impact Test-6 inside a 12-week, Double-blind, Randomized,
Phase 3 (PROGRESS) Trial for Preventive Treatment of Chronic Migraine (CM)

Friday, December 9

16: 00 – 16: 05 evening CET

ePoster

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

Fri, December nine

15: fifty five – sixteen: 00 pm hours CET

ePoster

Headache Disease

 

Characterizing Neck Pain with Headache in People with and without Migraine:
Comes from the Persistent Migraine Epidemiology and Results – International
(CaMEO-I) Study

Friday, December 9

15: 35 – fifteen: 40 pm CET

Late-Breaker ePoster

Characterizing Gaps in Preventive Treatment of Migraine: Global Results from
the particular CaMEO-International Research

Friday, December 9

15: 50 – 15: 55 pm CET

ePoster

Chronic Migraine Epidemiology and Final results – Worldwide (CaMEO-I) Study:
Methods and Worldwide Findings regarding Diagnosis Prices and Care

Friday, Dec 9

16: 45 – 16: 50 pm VOTRE

ePoster

OnabotulinumtoxinA

 

Evaluation of PREEMPT Fixed-dose, Fixed-site and Follow the Discomfort
Therapy Paradigms within the PREDICT Research

Friday, December 9

fifteen: 30 – 15: thirty-five pm CET

ePoster

Real-World Persistence plus Costs Among Patients with Chronic Headache
Treated with OnabotulinumtoxinA or CGRP mAbs: A Retrospective Claims
Analysis Study

Friday, Dec 9

sixteen: 25 – 16: thirty pm VOTRE

ePoster

The EHC 2022 will be a hybrid meeting taking location in-person and virtually. The full program for the congress can be found here .

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

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

QULIPTA will be a prescription medicine used for the particular preventive remedying of 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 plan to become pregnant. It is not known in case QULIPTA may harm your unborn baby
  • Are breastfeeding or plan to breastfeed. It is usually not known if QULIPTA passes into your breast milk. Talk in order to your doctor about the best way to feed your own baby while taking QULIPTA

Tell your doctor14929 about all the medicines you take , which includes prescription and over-the-counter medications, vitamins, plus herbal supplements. QULIPTA may affect the way other medicines work, and other medicines may affect how QULIPTA works. Your healthcare provider may need to change the dose of QULIPTA when taken along with certain other medicines.

The most common side effects of QULIPTA are nausea, constipation, and tiredness. These are not all the possible negative effects associated with QULIPTA.

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

If you are usually having difficulty paying for your own medicine, AbbVie may be able to help. Visit AbbVie. com/myAbbVieAssist in order to learn more.

Please see full Prescribing Information .

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

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

U. H. Indications and Important Security Information regarding BOTOX ® (onabotulinumtoxinA)

INDICATIONS

BOTOX ® (onabotulinumtoxinA) can be a prescription drugs that is injected into muscles and utilized:

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

BOTOX is also injected into the skin to treat the symptoms of serious underarm sweating (severe primary axillary hyperhidrosis) when medications used on the particular skin (topical) do not work well enough that individuals eighteen years and older.

It is far from recognized whether BOTOX is safe plus effective in order to prevent headaches in sufferers with migraine who have 14 or fewer headache days each month (episodic migraine).

BOTOX has not really been shown to help individuals perform task-specific functions along with their upper limbs or even increase movement in joints that are usually permanently fixed in position simply by stiff muscle tissue. It is not necessarily identified whether BOTOX is secure and effective designed for severe perspiration anywhere additional than your armpits.

IMPORTANT SAFETY INFORMATION

BOTOX may cause serious side effects that can be life threatening. Get healthcare help correct away if you have any associated with these issues any time (hours to weeks) right after injection of BOTOX:

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

There offers not already been a confirmed serious case of spread of contaminant effect aside from the particular injection web site when BOTOX has been used on the recommended dose in order to treat persistent migraine, severe underarm perspiring, blepharospasm, or strabismus.

BOTOX may trigger lack of power or general muscle some weakness, vision difficulties, or dizziness within hrs to weeks of receiving BOTOX. In case this happens, do not drive a car, operate machinery, or even do various other dangerous activities.

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

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

Patients treated for the purpose of overactive urinary: In clinical trials, 36 from the 552 individuals had to self-catheterize for urinary retention following therapy with BOTOX compared to 2 in the 542 treated with placebo. The median duration of postinjection catheterization with regard to these sufferers treated with BOTOX 100 Units (n = 36) was 63 days (minimum 1 day in order to maximum 214 days), because compared to a median life long 11 days (minimum 3 times to maximum 18 days) for patients receiving placebo (n = 2). Individuals with diabetes mellitus treated with BOTOX were more likely to develop urinary retention than nondiabetics.

Adult individuals treated regarding overactive bladder due in order to a neurologic disease: In clinical trials, 30. 6% of grownup patients (33/108) who were not really using clean intermittent catheterization (CIC) prior to shot required catheterization for urinary : retention following treatment along with BOTOX 200 Units, as compared to 6. 7% of sufferers (7/104) given placebo. The particular median duration of postinjection catheterization for these patients handled with BOTOX 200 Units (n sama dengan 33) was 289 days (minimum one day to optimum 530 days), as compared to the median life long 358 times (minimum two days to maximum 379 days) intended for patients getting placebo (n = 7).

Among mature patients not using CIC at baseline, those with multiple sclerosis were more prone to require CIC postinjection than those with spinal cord injury.

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

Serious and/or immediate allergic reactions possess been reported, including itching; rash; red, itchy welts; wheezing; asthma symptoms; fatigue; or feeling faint. Get medical assist right away if you experience symptoms; further injection of BOTOX should be discontinued.

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

Inform your doctor in case you have any breathing-related troubles. Your doctor might monitor a person for breathing problems throughout treatment along with BOTOX to get spasticity or for detrusor overactivity associated with a neurologic situation. The danger of developing lung condition in patients with reduced lung function is increased in individuals receiving BOTOX.

Cornea problems have been reported. Cornea (surface with the eye) complications have been reported in some people receiving BOTOX for their blepharospasm, especially in people with certain nerve disorders. BOTOX may result in the eyelids to blink less, which could lead to the surface of the eye being exposed in order to air a lot more than is certainly usual. Tell your doctor in case you experience any kind of problems with your eyes while receiving BOTOX. Your doctor may treat your own eyes along with drops, ointments, contact lenses, or with an eye patch.

Bleeding behind the eye has been documented. Bleeding at the rear of the eyeball has been reported in some individuals receiving BOTOX for their strabismus. Inform your physician if you notice any new visual problems whilst receiving BOTOX.

Bronchitis and top respiratory tract infections (common colds) happen to be documented. Bronchitis was reported more frequently in grown-ups receiving BOTOX for higher limb spasticity. Upper respiratory infections were also reported more frequently in adults with earlier breathing-related problems with spasticity. In pediatric patients treated with BOTOX pertaining to upper limb spasticity, upper respiratory system infections were reported more frequently. In pediatric sufferers treated along with BOTOX meant for lower arm or leg spasticity, top respiratory system infections were not reported more often compared to placebo.

Autonomic dysreflexia in patients treated designed for overactive urinary as a result of neurologic disease. Autonomic dysreflexia connected with intradetrusor injections of BOTOX could occur in patients dealt with for detrusor overactivity related with a neurologic problem and may require prompt medical therapy. Within trials, the particular incidence associated with autonomic dysreflexia was greater in adult patients taken care of with BOTOX 200 Models compared with placebo (1. 5% versus 0. 4%, respectively). Tell your doctor about all of your medical circumstances, including if you have got or have had bleeding issues; have plans to have surgery; had surgical treatment on your face; have weakness of forehead muscle groups, trouble raising your eyebrows, drooping eyelids, and any kind of other unusual facial change; have symptoms of an UTI and are getting treated just for bladder control problems (symptoms of an UTI may include pain or even burning along with urination, frequent urination, or fever); possess problems emptying your bladder on your own and they are being treated for urinary incontinence; are pregnant or intend to become expecting (it is not known if BOTOX can harm your unborn baby); are breastfeeding or even want to (it is not recognized if BOTOX passes into breast milk).

Tell your physician about all of the medicines you take, which includes prescription plus over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX with certain other medicines may cause severe unwanted effects. Do not start any new medicines until you have told your doctor that you have received BOTOX inside the past.

Say to your general practitioner if a person received any other botulinum toxin item in the last four months; have received injections associated with botulinum contaminant such while Myobloc ® , Dysport ® , or Xeomin ® in the past (tell your doctor exactly which product you received); have recently received a good antibiotic by injection; get muscle relaxants; take an allergy or cold medicine; take a sleep medicine; consider aspirin-like products or blood thinners.

Other part effects of BOTOX include dry mouth; discomfort or even pain within the injection site; tiredness; head ache; neck pain; eye difficulties such since double vision, blurred eyesight, decreased eyesight, drooping eyelids, swelling associated with your eyelids, and dry eyes; drooping eyebrows; plus upper respiratory tract infection. In adults being handled for bladder control problems, other unwanted side effects include UTI and painful urination. Inside children being treated for the purpose of urinary incontinence, other aspect effects consist of UTI and bacteria inside the urine. In patients being treated for urinary incontinence, another side effect includes the inability to empty your urinary by yourself. When you have got difficulty fully emptying your bladder on your own after getting BOTOX, you may need to make use of disposable self-catheters to empty your bladder up in order to a few times every day until your own bladder is able to start draining again.

For more information, refer to the Medication Guide or talk with your doctor.

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

In the event that you are having trouble spending money on your own medicine, AbbVie might be able to help. Visit AbbVie. com/myAbbVieAssist to learn a lot more.

Please observe BOTOX ® full Product Information , including Boxed Warning and Medication Manual .

Globally, recommending information differs; make reference to the particular individual nation product brand for total information.

About AbbVie in Migraine
Impacting 1 billion people worldwide, headache is the neurological disease with recurring attacks that will causes discomfort and other disabling symptoms. However , headache could 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 with regard to people impacted across the spectrum of migraine. Through education and partnerships with the headache community, we strive to assist those with migraine navigate barriers to care, access effective treatments plus reclaim their own lives.

About AbbVie
AbbVie’s mission is to discover and deliver innovative medications that solve serious health issues nowadays and address the healthcare challenges associated with tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, vision care, virology, women’s wellness and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. To find out more about AbbVie, please visit us at www.abbvie.com . Adhere to @AbbVie upon Twitter , Facebook , Instagram , YouTube and LinkedIn .

Forward-Looking Statements
Some statements in this news release are usually, or may be considered, forward-looking statements regarding 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 statements. AbbVie cautions that these forward-looking statements are subject to risks plus uncertainties that may cause actual results in order to differ materially from those indicated within the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie’s acquisition of Allergan plc (“Allergan”), failure to promptly plus effectively integrate Allergan’s businesses, competition through other items, challenges in order to intellectual property, difficulties inherent in 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, like COVID-19. Additional information regarding the economic, competitive, governmental, technological along with other factors that could affect AbbVie’s operations is set forth in Item 1A, “Risk Factors, ” of AbbVie’s 2021 Annual Report on Form 10-K, which has been filed using the Securities and Exchange Commission, as updated by the subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any kind of revisions to forward-looking claims as a result of subsequent events or even developments, except as needed by law.

Cision View original content: https://www.prnewswire.com/news-releases/abbvie-to-showcase-migraine-portfolio-and-pipeline-during-the-16th-european-headache-federation-congress-301695212.html

SOURCE AbbVie

Company Codes: NYSE: ABBV

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