AbbVie to Present Data from Growing Neuroscience and Movement Disorders Portfolio at 2022 MDS International Congress

--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 presented 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 management of movement disorders

NORTH CHICAGO, Ill., Sept. 15, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that data from its robust neuroscience portfolio will be presented at the 2022 International Parkinson and Movement Disorder Society's (MDS) International Congress, taking place in Madrid, Spain, from September 15-18. A total of 13 abstracts will be presented across multiple disease states, including Parkinson's disease, spasticity and 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 unmet needs," said Mudra Kapoor, M.D., vice president, neuroscience, global medical affairs, AbbVie. "Our research presented at this year's MDS International Congress reinforces our expertise in neuroscience and builds upon our mission to advance treatment for people living with these debilitating diseases."

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

AbbVie will also host a medical symposium on Thursday, September 15, from 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.

The 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 hall, all of which will become available after the in-person congress concludes. The full 2022 MDS International Congress program can be found here.

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 for 12 therapeutic indications, including chronic migraine, overactive bladder, leakage of urine (incontinence) due to overactive bladder caused by a 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 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 medicine that is injected into muscles and used:

• To treat overactive bladder symptoms such as a strong need to urinate with leaking or wetting accidents (urge urinary incontinence), a strong need to urinate right away (urgency), and urinating often (frequency) in adults 18 years and older when another type of medicine (anticholinergic) does not work well enough or cannot be taken
• To treat leakage of urine (incontinence) in adults 18 years and older with overactive bladder due to a neurologic disease when another type of medicine (anticholinergic) does not work well enough or cannot be taken
• To treat overactive bladder due to a neurologic disease 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 adults 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 in people 2 years of age and older with spasticity
• To treat the abnormal head position and neck pain that happens with cervical dystonia (CD) in people 16 years and older
• To treat certain types of eye muscle problems (strabismus) or abnormal 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 severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough in people 18 years and older.

It is not known whether BOTOX is safe and effective to prevent headaches in patients with migraine who have 14 or fewer headache days each 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 known whether BOTOX is safe and effective for severe sweating anywhere other than your armpits.

IMPORTANT SAFETY INFORMATION

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

• Problems swallowing, speaking, or breathing, due to weakening of associated muscles, 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 may affect areas away from the injection site and cause serious symptoms, including loss of strength and all-over muscle weakness; double vision; blurred vision; drooping eyelids; hoarseness or change or loss of voice; trouble saying words clearly; loss of bladder control; trouble breathing; and trouble swallowing.

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

BOTOX may cause loss of strength or general muscle weakness, vision problems, or 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 of the ingredients in BOTOX (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.

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

Patients treated for overactive bladder: In clinical trials, 36 of the 552 patients had to self-catheterize for urinary retention following treatment with BOTOX compared to 2 of 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 duration of 11 days (minimum 3 days to maximum 18 days) for patients receiving placebo (n = 2). Patients with diabetes mellitus treated with BOTOX were more likely to develop urinary retention than nondiabetics.

Adult patients treated for overactive bladder due to a neurologic disease: In clinical trials, 30.6% of adult patients (33/108) who were not using clean intermittent catheterization (CIC) prior to injection required catheterization for urinary retention following treatment with BOTOX 200 Units, as compared to 6.7% of patients (7/104) treated with placebo. The median duration of postinjection catheterization for these patients treated with BOTOX 200 Units (n = 33) was 289 days (minimum 1 day to maximum 530 days), as compared to a median duration of 358 days (minimum 2 days to maximum 379 days) for patients receiving placebo (n = 7).

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

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

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

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

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

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

Bleeding behind the eye has been reported. Bleeding behind the eyeball has been reported in some people receiving BOTOX for their strabismus. Tell your doctor if you notice any new visual problems while receiving BOTOX.

Bronchitis and upper respiratory tract infections (common colds) have been reported. Bronchitis was reported more frequently in adults receiving BOTOX for upper limb spasticity. Upper respiratory infections were also reported more frequently in adults with prior breathing-related problems with spasticity. In pediatric patients treated with BOTOX for upper limb spasticity, upper respiratory tract infections were reported more frequently. In pediatric patients treated with BOTOX for lower limb spasticity, upper respiratory tract infections were not reported more frequently than placebo.

Autonomic dysreflexia in patients treated for overactive bladder due to a neurologic disease. Autonomic dysreflexia associated with intradetrusor injections of BOTOX could occur in patients treated 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 adult patients treated with BOTOX 200 Units 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; have plans to have surgery; had surgery on your face; have weakness of forehead muscles, trouble raising your eyebrows, drooping eyelids, and any other abnormal facial change; have symptoms of a UTI and are being treated for urinary incontinence (symptoms of a UTI may include pain or burning with urination, frequent urination, or fever); have problems emptying your bladder on your own and are being treated for urinary incontinence; are pregnant or plan to become pregnant (it is not known if BOTOX can harm your unborn baby); are breastfeeding or plan to (it is not known if BOTOX passes into breast milk).

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX in the past.

Tell your doctor if you received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc®, Dysport®, or Xeomin® in the past (tell your doctor exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take aspirin-like products or blood thinners.

Other side effects of BOTOX include dry mouth; discomfort or pain at the injection site; tiredness; headache; neck pain; eye problems such as double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes; drooping eyebrows; and upper respiratory tract infection. In adults being treated for urinary incontinence, other side effects include UTI and painful urination. In children being treated for urinary incontinence, other side effects include UTI and bacteria in the urine. In patients being treated for urinary incontinence, another side effect includes the inability to empty your bladder on your own. If you have difficulty fully emptying your bladder 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 until your bladder is able to start emptying again.

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

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

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

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

U.S. Indication and Important Safety Information About DUOPA® (levodopa/carbidopa)

DUOPA (carbidopa and levodopa) enteral suspension is indicated for the treatment of motor fluctuations in patients with advanced Parkinson's disease.

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

• Stomach and intestine (gastrointestinal) problems and problems from the procedure you will need to have to receive DUOPA (gastrointestinal procedure-related problems) may occur. Some of these problems may require surgery and may lead to death.
• Serious side effects may include: a blockage of your stomach or intestines (bezoar); stopping movement through intestines (ileus); drainage, redness, swelling, pain, feeling of warmth around the small hole in your stomach wall (stoma); bleeding from stomach ulcers or your intestines; inflammation of your pancreas (pancreatitis); infection in your lungs (pneumonia); air or gas in your abdominal cavity; skin infection around the intestinal tube, pocket of infection (abscess), or infection in your blood (sepsis) or abdominal cavity may occur after surgery; stomach pain, nausea, or vomiting.
• Tell your healthcare provider right away if you have any of the following symptoms of stomach and intestine problems and gastrointestinal procedure-related problems: stomach (abdominal) pain; constipation that does not go away; nausea or vomiting; fever; blood in your stool; or a dark tarry stool.

Your healthcare provider will talk to you about the stoma procedure. Before the stoma procedure, tell your healthcare provider if you ever had a surgery or problems with your stomach.

Talk to your healthcare provider about what you need to do to care for your stoma. After the procedure, you and your healthcare provider will need to regularly check the stoma for any signs of infection.

Do not take DUOPA if you currently take or have recently taken (within 2 weeks) a medication for depression called a 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 healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using DUOPA with certain other medicines, including medications for high blood pressure, MAO inhibitors, antipsychotics, metoclopramide, isoniazid, and iron or vitamin supplements, may cause serious side effects. High-protein foods may affect how DUOPA works. Tell your healthcare provider if you change your diet.

DUOPA may cause serious side effects. Talk to your doctor before starting DUOPA and while on DUOPA if you have had or have any of these:

• Falling asleep during normal daily activities without warning. DUOPA may cause you to fall asleep while you are doing daily activities such as driving, which may result in an accident. This can happen as late as one year after starting DUOPA. Do not drive or operate machinery until you know how DUOPA affects you. Tell your healthcare provider if you take medicines that can make you sleepy, such as sleep medicines, antidepressants, or antipsychotics.
• Low blood pressure when you stand or sit up quickly. After you have been sitting or lying down, stand up slowly to help reduce dizziness, nausea, sweating, or fainting until you know how DUOPA affects you.
• Seeing, hearing, or feeling things that are not real (hallucinations).
• Unusual urges. Some people taking medicines for Parkinson's disease, including DUOPA, have reported urges such as excessive gambling, compulsive eating, compulsive shopping, and increased sex drive.
• Depression and suicide. DUOPA can cause or worsen depression. Pay close attention to changes in your mood, behavior, thoughts, or feelings. Call your healthcare provider right away if you feel depressed or have thoughts of suicide.
• Uncontrolled sudden movements (dyskinesia). If you have new dyskinesia or your dyskinesia gets worse, tell your healthcare provider. This may be a sign that your dose of DUOPA or other Parkinson's medicines may need to be adjusted.
• Progressive weakness or numbness or loss of sensation in the fingers or feet (neuropathy).
• Heart attack or other heart problems. Tell your healthcare provider if you have experienced increased blood pressure, a fast or irregular heartbeat, or chest pain.
• Abnormal blood tests. DUOPA may cause changes in certain blood tests, especially certain hormone and kidney function blood tests.
• Worsening of the increased pressure in your eyes (glaucoma). The pressure in your eyes should be checked after starting DUOPA.

Do not stop using DUOPA or change your dose unless you are told to do so by your healthcare provider. Tell your healthcare provider if you develop withdrawal symptoms such as fever, confusion, or severe muscle stiffness.

The most common side effects of DUOPA include: complications of tubing placement procedure, swelling of legs and feet, nausea, high blood pressure (hypertension), depression, and mouth and throat pain.

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

Please see the full Prescribing Information including Medication Guide for additional information about DUOPA. Talk to your healthcare provider if you have questions.

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

About ABBV-951
ABBV-951 is an investigational subcutaneous delivery of levodopa/carbidopa being evaluated for the treatment of advanced levodopa-responsive Parkinson's disease with severe motor fluctuations and hyperkinesia or dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results. ABBV-951 is an investigational therapy and it is not approved for use.

About AbbVie in Neuroscience
At AbbVie, our commitment to preserve the personhood of those living 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 for patients, care partners and clinicians. AbbVie's Neuroscience portfolio consists of approved therapies and a robust pipeline in neurological and psychiatric disorders, 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 strong investment in neuroscience research, with our Foundational Neuroscience Center in Cambridge, Massachusetts, and our Neuroscience Discovery site in Ludwigshafen, Germany, where our research and resilience in these challenging therapeutic areas is yielding a deeper understanding of the pathophysiology of neurological and psychiatric disorders, and identifying targets for potential disease-modifying therapeutics aimed at making a difference in people's lives.

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For 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 news release are, or may be considered, forward-looking statements for 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 and uncertainties that may cause actual results to differ materially from those indicated in 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 and effectively integrate Allergan's businesses, competition from other products, challenges 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 of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other 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 been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

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SOURCE AbbVie