–Results will be presented from the Phase 3 M15-736 trial, a randomized, double-blind, double-dummy, active-controlled study, evaluating the continuous subcutaneous infusion of ABBV-951 (foslevodopa/foscarbidopa) in people with advanced Parkinson’s disease
–Data will also be offered on real-world efficacy of BOTOX ® (onabotulinumtoxinA) for the treatment of spasticity and BOTOX ® for the treatment of cervical dystonia
–Research highlights AbbVie’s continued commitment to advancing the particular management associated with movement disorders

NORTH CHICAGO, Ill. , Sept. 15, 2022 /PRNewswire/ —  AbbVie (NYSE: ABBV) today announced that  data from its robust neuroscience portfolio will be introduced at the 2022 Worldwide Parkinson and Movement Disorder Society’s (MDS) International Congress, taking place within Madrid, Spain , through September 15-18 . A total of 13 abstracts will be presented across multiple disease states, including Parkinson’s illness, spasticity plus cervical dystonia.

“At AbbVie, we understand the realities and challenges that people living with movement disorders face and are relentless in our pursuit to address the particular unmet needs, ” said  Mudra Kapoor, M. D., vice president, neuroscience, global medical affairs, AbbVie. “Our research shown at this year’s MDS Global Congress reinforces our expertise in neuroscience and builds upon our mission in order to advance therapy for individuals coping with these debilitating diseases. ”

At MDS, researchers will present results from M15-736, a randomized, double-blind, double-dummy, active-controlled Stage 3 study, evaluating the continuous subcutaneous infusion associated with ABBV-951 (foslevodopa/foscarbidopa) in people with advanced Parkinson’s condition, as well as real-life data from the ASPIRE study, analyzing BOTOX ® for that treatment of spasticity. The data is going to be presented during the guided poster tours.

AbbVie will furthermore host the medical symposium on Thursday, September 15 , through 13: 30-14: 30 Central European Summer Time (CEST) titled “Transforming care towards a patient-centered approach to early identification of suboptimal PD control, ” featuring physicians who will discuss the rationale for improving care in Parkinson’s disease patients whose symptoms remain uncontrolled on oral medications.

AbbVie abstracts presented at the 2022 MDS International Congress are outlined below.  

Key AbbVie Abstracts at 2022 MDS Worldwide Congress

Abstract Title

Abstract Details

Advanced Parkinson’s Disease

Subcutaneous Foslevodopa/Foscarbidopa in Patients with Sophisticated Parkinson’s Illness: Results from a Randomized,
Double-Blind, Double-Dummy Phase 3 Trial

Friday, September 16

13: 00-15: 00 CEST

Guided Poster Tour

Impact associated with Foslevodopa/Foscarbidopa upon Key Clinical and Patient-Reported Outcomes within Patients along with aPD: Responder
Analysis of Two Phase 3 Medical Trials

Fri, September sixteen
14: 00-14: 30
CEST

Concomitant Medication Use and Levodopa Equivalent Daily Dose Requirements After Foslevodopa/foscarbidopa Initiation

Friday, September 16
13: 00-15: 00 CEST

Guided Poster Trip

Rapid Onset associated with Good ON Time and Improvement in Motor-State Stability in aPD Individuals After Treatment with Continuous
Subcutaneous Foslevodopa/Foscarbidopa

Friday, September 16
thirteen: 00-15: 00 CEST

Guided Poster Tour

Patient and Caregiver Satisfaction of Video-Assisted Telenursing within Patients Treated with Levodopa/Carbidopa Intestinal
Gel (LCIG)

Thurs, September fifteen
14: 00-14: 30
CEST

Scientific Outcomes plus Disease Burden of Superior Parkinson’s Condition Patients Given Oral Medication Vs.
Device-Aided Therapies: Preliminary Results through the University of Florida Registry Analysis

Saturday, Sept 17
13: 00-13: 30
CEST

Reported Clinical and Quality-of-Life Outcomes with 24-Hour Levodopa-Compared with 16-Hour Administration

Saturday, September 17
13: 00-13: 30
CEST

  Spasticity

Pain and Disability Outcomes in Hemiparetic Patients Naive to Botulinum Toxins along with Upper and Lower Limb Spasticity Treated
with OnabotulinumtoxinA: Insights from your DESIRE Study

Fri, September sixteen
13: 00-13: 30
CEST

Treating Upper Arm or leg Spasticity along with OnabotulinumtoxinA: Subgroup Analysis of US Practice Patterns through the ASPIRE Research

Friday, September 16
14: 00-14: thirty CEST

Guided Poster Tour

Real-World Medical Utilization Differences of OnabotulinumtoxinA and AbobotulinumtoxinA in Upper Limb Spasticity

Friday, Sept 16
fourteen: 30-15: 00
CEST

Pain plus Disability Results in Hemiparetic Patients with Post-Stroke Spasticity: Exploratory Evaluation of the particular ASPIRE Study

Friday, September 16
14: 30-15: 00
CEST

Cervical Dystonia

Characteristics and Therapy Response to OnabotulinumtoxinA of Sufferers from CD-PROBE with Retrocollis Subtype associated with
Cervical Dystonia

Friday, Sept 16
thirteen: 00-13: 30 CEST

Features and Treatment Reaction to OnabotulinumtoxinA of Patients from CD-PROBE with Anterocollis Subtype of
Cervical Dystonia

Friday, September 16
13: 00-13: 30 CEST

The particular 2022 MDS International Congress is a hybrid meeting taking place in-person and virtually. The virtual platform features on-demand recordings of scientific sessions, a poster hall, and an exhibition corridor, all associated with which will certainly become available after the in-person congress concludes. The full 2022 MDS International Our elected representatives program can be found here .

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

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

INDICATIONS

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

  • To treat overactive bladder symptoms such as a strong need to urinate along with leaking or wetting accidents (urge urinary incontinence), a strong need to urinate right away (urgency), plus urinating often (frequency) in grown-ups 18 years and older when another type of medication (anticholinergic) does not work well enough or cannot be taken
  • To treat leakage associated with urine (incontinence) in adults 18 a number of old with overactive bladder due to the neurologic illness when another type of medicine (anticholinergic) can not work well enough or even cannot become taken
  • In order to treat overactive bladder due to a neurologic condition in children 5 years of age and older when another type of medicine (anticholinergic) does not work well enough or cannot 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 years and older
  • To treat increased muscle stiffness that individuals 2 many years of age and older with spasticity
  • To treat the abnormal head position plus neck pain that happens with cervical dystonia (CD) in individuals sixteen a number of old
  • To deal with certain types of vision muscle problems (strabismus) or abnormal spasm of the particular eyelids (blepharospasm) in persons 12 years old and older

BOTOX is also injected into the skin to deal with the symptoms associated with severe underarm sweating (severe primary axillary hyperhidrosis) whenever medicines utilized on the skin (topical) do not work nicely enough in people eighteen years and older.

It is not really known whether BOTOX will be safe plus effective to prevent headaches within patients along with migraine that have 14 or even fewer head ache days every month (episodic migraine).

BOTOX has not been shown in order to help people perform task-specific functions with their upper limbs or increase motion in joints that are permanently fixed in position by stiff muscle tissue. It is usually not known whether BOTOX is safe and effective for serious sweating anywhere other than your armpits.

IMPORTANT SAFETY INFORMATION

BOTOX may cause serious side effects that can end up being life threatening. Get medical help immediately if you have any of these issues any time (hours to weeks) after injection of BOTOX:

  • Problems swallowing, speaking, or even breathing , due to weakening of associated muscles, may be severe and result in loss of life. You are at the highest risk if these types of problems are preexisting before injection. Swallowing problems may last for several months.
  • Spread associated with toxin effects. The effect of botulinum toxin may affect areas away from the shot site and cause severe 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 in urinary control; trouble breathing; plus trouble ingesting.

There has not been a confirmed serious case of spread of toxin effect away from injection site when BOTOX has already been used in the recommended dose to treat chronic headache, severe armpit sweating, blepharospasm, or strabismus.

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

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

Do not receive BOTOX for the treatment of urinary : incontinence in case you   have a good urinary tract infection (UTI) or are not able to empty your own bladder on your own and are not routinely catheterizing. Due to the danger of urinary retention (difficulty fully emptying the bladder), only individuals 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 of the 552 patients had to self-catheterize intended for urinary retention following treatment with BOTOX compared in order to 2 associated with the 542 treated with placebo. The median duration of postinjection catheterization for these patients treated with BOTOX 100 Units (n = 36) was 63 days (minimum 1 day to maximum 214 days), as compared to a median period of 11 days (minimum 3 days to optimum 18 days) for sufferers receiving placebo (n = 2). Individuals with diabetes mellitus given BOTOX were more likely to develop urinary preservation than nondiabetics.

Adult patients handled for overactive bladder as a result of neurologic disease:   In clinical trials, 30. 6% of adult patients (33/108) who had been not using clean intermittent catheterization (CIC) prior to injection required catheterization for urinary : retention following treatment along with BOTOX 200 Units, because compared to 6. 7% of patients (7/104) dealt with placebo. The median duration of postinjection catheterization for people individuals treated with BOTOX 200 Units (n sama dengan 33) has been 289 times (minimum 1 day in order to maximum 530 days), when compared with a median duration associated with 358 days (minimum 2 days to maximum 379 days) to get patients receiving placebo (n = 7).

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

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

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

Tell your doctor about all your muscle or even nerve conditions, such since ALS or Lou Gehrig’s disease, myasthenia gravis, or even Lambert-Eaton syndrome, as you may be at increased risk of serious negative effects, including difficulty swallowing and difficulty breathing from typical dosages of BOTOX.

Inform your physician if a person have any breathing-related difficulties.   Your doctor may monitor you pertaining to breathing problems during treatment with BOTOX meant for spasticity or for detrusor overactivity connected with the neurologic situation. The risk of developing lung illness in sufferers with reduced lung function is improved in patients receiving BOTOX.

Cornea problems possess been reported. Cornea (surface of the particular eye) problems have been documented in some individuals receiving BOTOX for their blepharospasm, especially in people with particular nerve disorders. BOTOX might cause the eyelids to blink less, which could lead to the surface of the attention being exposed to air more than is usual. Tell your doctor in case you experience any problems with your eyes while getting BOTOX. Your doctor may treat your eye with drops, ointments, contact lenses, or with an eye patch.

Bleeding behind the eye has been reported. Bleeding at the rear of the eyeball has been reported within some individuals receiving BOTOX for their strabismus. Tell your physician if you notice any kind of new visual problems while receiving BOTOX.

Bronchitis and top respiratory system infections (common colds) have got been documented.   Bronchitis had been reported more frequently in grown ups receiving BOTOX for higher limb spasticity. Upper respiratory infections had been also reported more frequently in adults along with prior breathing-related issues with spasticity. In pediatric patients taken care of with BOTOX for upper limb spasticity, upper respiratory tract infections were reported more often. In pediatric patients given BOTOX designed for lower limb spasticity, top respiratory tract infections had been not documented more regularly than placebo.

Autonomic dysreflexia in patients treated for overactive bladder because of to a neurologic condition.   Autonomic dysreflexia associated with intradetrusor injections associated with BOTOX could occur in individuals treated just for detrusor overactivity associated with a neurologic condition plus may need prompt healthcare therapy. Within clinical tests, the incidence of autonomic dysreflexia was greater within adult sufferers treated with BOTOX 200 Models compared with placebo (1. 5% versus 0. 4%, respectively). Tell your doctor about all your medical conditions, including if you have or have had bleeding problems; possess plans to have surgery; experienced surgery on your face; have got weakness of forehead muscle groups, trouble raising your eyebrows, drooping eyelids, and any other abnormal facial change; have symptoms associated with an UTI and are being handled for urinary incontinence (symptoms of an UTI might include pain or burning with urination, frequent peeing, or fever); have troubles emptying your own bladder on your own and are usually being dealt with for urinary : incontinence; are pregnant or even plan in order to become pregnant (it is just not recognized if BOTOX can harm your unborn baby); are breastfeeding or plan to (it is not known when BOTOX passes into breast milk).

Inform your physician about almost all the medicines you take,   including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX with specific other medications may cause serious side effects. Usually do not start any new medicines until a person have told your doctor that will you possess received BOTOX in the past.

Tell your doctor in the event you received some other botulinum toxin product in the last four months; have got received injections of botulinum toxin like Myobloc ® , Dysport ® , or Xeomin ® in the past (tell your physician exactly which product you received); have recently obtained an antibiotic by injection; take muscle tissue relaxants; get an allergy or cold medicine; consider a sleep medicine; take aspirin-like products or blood thinners.

Other unwanted effects of BOTOX include dry mouth; discomfort or pain at the particular injection site; tiredness; headaches; neck discomfort; eye complications for example double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dried out eyes; sagging eyebrows; and upper respiratory tract infection. In adults being taken care of for urinary incontinence, some other side results include UTI and painful urination. In children being treated for urinary incontinence, additional unwanted side effects include UTI plus bacteria in the urine. In patients being treated for bladder control problems, another side effect includes the inability to empty your bladder on your own. If you have difficulty fully emptying your bladder by yourself after receiving BOTOX, you may need to use disposable self-catheters to empty your own bladder up to a few times each day time until your bladder is definitely able in order to start draining again.

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

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

If you are having problems paying with regard to your medicine, AbbVie may be able to assist. Visit AbbVie. com/myAbbVieAssist to learn more.

Please see BOTOX ® complete Product Information , which includes Boxed Warning and Medication Guide .

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

Oughout. S. Indication and Essential Safety Info About DUOPA ® (levodopa/carbidopa)

DUOPA (carbidopa and levodopa) enteral suspension is indicated for the particular remedying of motor fluctuations within patients with advanced Parkinson’s disease.

What is the most important safety information I should know about DUOPA?

  • Stomach and intestine (gastrointestinal) problems plus problems through the procedure you may need in order to have to get DUOPA (gastrointestinal procedure-related problems) may occur. Some of these problems may require surgery and may lead to death.
    • Serious side-effects may consist of: a blockage of the stomach or intestines (bezoar); stopping movement through intestines (ileus); drainage, redness, swelling, pain, feeling of warmth around the small hole in your belly wall (stoma); bleeding from stomach ulcers or your own intestines; inflammation of your respective pancreas (pancreatitis); contamination in your lungs (pneumonia); air flow or gas within your abdominal cavity; pores and skin infection around the intestinal tube, pocket of illness (abscess), or infection inside your blood (sepsis) or stomach cavity might occur right after surgery; abdomen pain, nausea, or vomiting.
  • Inform your healthcare provider instantly in the event that you possess any of the subsequent symptoms of tummy and intestine problems and gastrointestinal procedure-related problems: stomach (abdominal) discomfort; constipation that does not really go away; nausea or vomiting or throwing up; fever; bloodstream in the stool; or a dark tarry feces.

Your healthcare provider can talk to a person about the stoma procedure. Before the stoma procedure , tell your doctor if you ever had a surgery or issues with your own stomach.

Talk to your doctor14929 about what you need to do in order to care for your stoma. After the process, you plus your healthcare provider will need to regularly check the stoma regarding any signs of infection.

Do not take DUOPA should you currently take or even have recently taken (within 2 weeks) a medication for depression called the non-selective monoamine oxidase (MAO) inhibitor. Ask your healthcare provider or pharmacist if you are not sure if you take an MAO inhibitor.

Tell your own doctor regarding all the medications   you take, including prescription and over-the-counter medicines, vitamins, plus herbal medicines. Using DUOPA along with certain various other medicines, which includes medications intended for high blood pressure, MAO inhibitors, antipsychotics, metoclopramide, isoniazid, and iron or vitamin supplements, could potentially cause serious adverse reactions. High-protein foods may affect how DUOPA works. Tell your healthcare supplier when you change your diet.

DUOPA may trigger serious part effects. Talk to your doctor before starting DUOPA and while on DUOPA if a person have got or have got some of these:

  • Falling asleep throughout normal daily activities without warning. DUOPA will cause you to fall asleep whilst you are usually doing every day activities for instance driving, which may result within an accident. This can happen as late as 1 year after starting DUOPA. Tend not to generate or operate machinery until you know how DUOPA affects you. Inform your healthcare service provider for medications that can make you sleepy, such as sleep medicines, antidepressants, or even antipsychotics.
  • Low blood pressure when you stand or sit up quickly. Right after you have been sitting or lying down, stand up slowly to help reduce dizziness, feeling sick, sweating, or even fainting until you know how DUOPA impacts you.
  • Seeing, hearing, or feeling things that are not really real (hallucinations).
  • Unusual urges. Some people getting medicines to get Parkinson’s disease, including DUOPA, have reported urges including excessive gambling, compulsive eating, compulsive shopping, and increased sex drive.
  • Depression and suicide. DUOPA can cause or worsen depressive disorders. Pay close attention in order to changes in your mood, behavior, thoughts, or even feelings. Call your doctor14929 right away if you feel depressed or have thoughts of committing suicide.
  • Uncontrolled sudden movements (dyskinesia). If you possess new dyskinesia or your dyskinesia gets worse, tell your health care provider. This may be a sign that your dose of DUOPA or other Parkinson’s medications may need to become adjusted.
  • Progressive weakness or numbness or loss of sensation in the particular fingers or feet (neuropathy).
  • Heart attack or even other heart problems. Tell your own healthcare provider in case you have got experienced improved blood pressure, a fast or irregular heartbeat, or chest pain.
  • Abnormal blood tests. DUOPA might result in changes in certain bloodstream tests, especially certain hormone and kidney function blood tests.
  • Worsening of the increased pressure within your eyes (glaucoma). The pressure in your eyes should be checked after starting DUOPA.

Never stop making use of DUOPA or even change your own dose unless you are told to do so by your doctor. Inform your doctor14929 if you develop withdrawal symptoms such as fever, confusion, or severe muscles stiffness.

The most common side effects of DUOPA include: complications of tubing placement treatment, swelling associated with legs and feet, nausea, hypertension (hypertension), depression, plus mouth and throat pain.

A person are encouraged to report negative aspect effects of doctor prescribed drugs to the FDA. Visit www.fda.gov/medwatch or even call 1-800-FDA-1088.

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

Please see the full Prescribing Information including Medication Manual for additional info about DUOPA. Talk to your healthcare provider if a person have questions.

Globally, prescribing details varies; make reference to the individual country item label pertaining to complete information.

About ABBV-951
ABBV-951 can be an investigational subcutaneous delivery of levodopa/carbidopa being evaluated for the particular take care of sophisticated levodopa-responsive Parkinson’s disease with severe engine fluctuations and hyperkinesia or dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory outcomes.   ABBV-951 is an investigational therapy plus it is certainly not approved for use.

About AbbVie in Neuroscience
At AbbVie, our commitment in order to preserve the personhood of those living along with neurological and psychiatric disorders is unwavering. Every challenge in this uncharted territory makes us more determined and drives us harder to discover and deliver solutions meant for patients, care partners plus clinicians. AbbVie’s Neuroscience portfolio consists of authorized therapies and a robust pipeline in neurological plus psychiatric problems, including Alzheimer’s disease,   bipolar I disorder, major depressive disorder, migraine, Parkinson’s disease,   spinal cord injuries, post-stroke spasticity, schizophrenia, stroke and others.

We have a solid investment within neuroscience research, with our Foundational Neuroscience Center in  Cambridge, Massachusetts , and our own Neuroscience Discovery site in Ludwigshafen,   Germany, where our study and resilience in these challenging therapeutic areas is yielding a deeper understanding of the particular pathophysiology of neurological plus psychiatric disorders, and identifying targets designed for potential disease-modifying therapeutics aimed at making a difference within people’s lives.

Regarding AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that will solve severe health issues today plus address the medical difficulties of tomorrow. We strive to have a remarkable impact on people’s life across a number of key restorative areas: immunology, oncology, neuroscience, eye treatment, virology, women’s health  and  gastroenterology,   in  addition  to  products  and  services  across the Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @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 just for purposes associated with 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 and uncertainties that may cause actual results to differ materially from all those indicated in the forward-looking statements. Such risks plus uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie’s acquisition of Allergan plc (“Allergan”), failure in order to promptly and effectively integrate Allergan’s businesses, competition through other items, challenges to intellectual property, difficulties inherent in the particular research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, just like COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that could affect AbbVie’s operations is set forth within Item 1A, “Risk Factors, ” associated with AbbVie’s 2021 Annual Report on Form 10-K, which has been filed with the Securities plus Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any kind of revisions in order to forward-looking claims as a result of subsequent events or even developments, except as needed by law.

SOURCE AbbVie

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