AbbVie (NYSE: ABBV) today announced new data from its expansive neuroscience portfolio will be presented at the 2021 American Academy of Neurology (AAN) Annual Meeting, to be held virtually from April 17-22. A total of 33 abstracts, including one podium presentation during the Clinical Trials Plenary Session and three oral presentations, will be shared from a broad range of studies across the spectrum of migraine, advanced Parkinson's disease and spasticity.
"Our strong presence at AAN reflects our expanded portfolio of approved and investigational treatments designed to address a wide range of complicated, often debilitating neurological disorders," said Michael Gold, M.D., vice president, neuroscience development, AbbVie. "We look forward to sharing our progress in a number of areas, including pivotal Phase 3 data in migraine, with the goal of making a remarkable impact on patients' lives."
Researchers will present data from several studies on migraine, including new findings on atogepant, AbbVie's investigational preventive treatment of migraine in adults who meet criteria for episodic migraine as well as results evaluating the efficacy and safety of BOTOX(R) (onabotulinumtoxinA) and UBRELVY(R) (ubrogepant).
In addition, investigators will present the study design of the Phase 3 study assessing the efficacy and safety of the investigational treatment ABBV-951 (foslevodopa/foscarbidopa), a levodopa/carbidopa prodrug administered as a 24-hour continuous, subcutaneous infusion in people with advanced Parkinson's disease.
Key AbbVie abstracts and presentation details for the 2021 AAN Annual Meeting program are outlined below. Posters will be available during and for 30 days following the meeting.
Abstract Title Presentation Details All times CT Migraine Atogepant Significantly Reduces Mean Monthly Migraine Days in the Phase 3 Trial (ADVANCE) for the Prevention of Migraine Clinical Trials Plenary Session Tuesday, April 20 9:15 a.m. CT Long-term Safety and Tolerability of Atogepant 60 mg Following Once Daily Dosing Over 1 year for the Preventive Treatment of Migraine S5: Headache 1 Saturday, April 17 3 p.m. CT Atogepant Improved Patient-Reported Migraine-Specific Quality of Life in a 12-Week Phase 3 (ADVANCE) Trial for Preventive Treatment of Migraine Poster Atogepant Improved Patient-Reported Outcome (PRO) Measures of Activity Impairment in Migraine-Diary and Headache Impact Test in a 12-Week, Double-blind, Randomized Phase 3 (ADVANCE) Trial for Preventive Treatment of Migraine Poster Ubrogepant Was Safe and Well Tolerated in the Acute Treatment of Perimenstrual Migraine S5: Headache 1 Saturday, April 17 3:32 p.m. CT Assessing Barriers to Care in Episodic and Chronic Migraine: Results From the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study S15: Headache 2 Monday, April 19 1:32 p.m. CT Characterizing Preventive Treatment Gaps in Migraine: Results from the CaMEO Study Poster Real-World Evidence for Control of Chronic Migraine (CM) in Patients Meeting American Headache Society (AHS) Criteria Who Received Calcitonin Gene-Related Peptide Monoclonal Antibody (CGRPmAb) Therapy Added to OnabotulinumtoxinA Treatment Poster Real-World Evidence for Control of Patients With Chronic Migraine Who Received CGRP Monoclonal Antibody Therapy Added to OnabotulinumtoxinA Treatment Poster Consecutive Headache-Free Days With OnabotulinumtoxinA Treatment in Patients With Chronic Migraine: A Pooled PREEMPT Analysis Poster Real-World Safety and Efficacy of 155-195U OnabotulinumtoxinA in Participants With Chronic Migraine: Results From the REPOSE Study Poster Advanced Parkinson's Disease Efficacy and Safety of Subcutaneous Foslevodopa/Foscarbidopa Versus Oral Levodopa/Carbidopa in Advanced Parkinson's Disease Patients: Design of a Phase 3, Randomized, Double-blind, Double-dummy, Active Controlled 12-Week Trial Poster Identifying Care Gaps in Parkinson's Disease Patients Eligible for Device-Aided Therapies: Results from Using the MANAGE-PD Tool in Patients from G7 Countries Poster Unmet Needs and Treatment Patterns of Advanced Parkinson's Disease Patients in the United States Poster A Retrospective Study Evaluating the Use of Anti-Parkinsonian Medications in Patients with Advanced Parkinson's Disease Who Are Treated with Levodopa-Carbidopa Intestinal Gel and Deep Brain Stimulation: The PD-DUAL Study Poster Sustained Improvements in Motor and Non-Motor Symptoms in Advanced Parkinson's Disease Patients Treated with Carbidopa Levodopa Enteral Suspension in a 'Real-World' Study: Interim Results of the Multinational DUOGLOBE Study With at least 24 Months Follow-Up Poster Spasticity Consistent Dosing Over Time and Within Treatment Interval Groups with OnabotulinumtoxinA: Analysis from the Adult Spasticity International Registry (ASPIRE) Poster
A full list of all 33 AbbVie abstracts accepted for presentation at the 2021 AAN Annual Meeting can be found here.
About AtogepantAtogepant is an investigational orally administered, CGRP receptor antagonist (gepant) specifically developed for the preventive treatment of migraine. 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 and selective CGRP receptor antagonists confer clinical benefit in migraine.
The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for atogepant. AbbVie anticipates a regulatory decision in late Q3 2021.
About ABBV-951ABBV-951 (foslevodopa/foscarbidopa) is a continuous subcutaneous infusion being investigated for the treatment of advanced Parkinson's disease.
About BOTOX(R)BOTOX(R) was first approved by the FDA in 1989 for two rare eye muscle disorders - blepharospasm and strabismus in adults. Today, BOTOX(R) 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, cervical dystonia, adult and pediatric spasticity, severe underarm sweating (axillary hyperhidrosis), and pediatric detrusor overactivity associated with a neurologic condition.
BOTOX(R) (onabotulinumtoxinA) Important Information
IndicationsBOTOX(R) 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 caused by a neurologic disease who still have leakage or cannot tolerate the side effects after trying an anticholinergic medication
-- 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 or 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(R) 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(R) is safe and effective to prevent headaches in patients with migraine who have 14 or fewer headache days each month (episodic migraine).
BOTOX(R) 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(R) is safe and effective for severe sweating anywhere other than your armpits.
IMPORTANT SAFETY INFORMATIONBOTOX(R) 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(R):
-- 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 pre-existing 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 and 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(R) has been used at the recommended dose to treat chronic migraine, severe underarm sweating, blepharospasm, or strabismus.
BOTOX(R) may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX(R). If this happens, do not drive a car, operate machinery, or do other dangerous activities.
Do not receive BOTOX(R) if you: are allergic to any of the ingredients in BOTOX(R) (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc(R) (rimabotulinumtoxinB), Dysport(R) (abobotulinumtoxinA), or Xeomin(R) (incobotulinumtoxinA); have a skin infection at the planned injection site.
Do not receive BOTOX(R) 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 (not being able to empty the bladder), only patients who are willing and able to initiate catheterization post treatment, 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(R) compared to 2 of the 542 treated with placebo. The median duration of post-injection catheterization for these patients treated with BOTOX(R) 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(R) were more likely to develop urinary retention than nondiabetics.
Adult Patients treated for overactive bladder due to neurologic disease:In clinical trials, 30.6% of patients (33/108) who were not using clean intermittent catheterization (CIC) prior to injection, required catheterization for urinary retention following treatment with BOTOX(R) 200 Units as compared to 6.7% of patients (7/104) treated with placebo. The median duration of post-injection catheterization for these patients treated with BOTOX(R) 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 patients not using CIC at baseline, those with MS were more likely to require CIC post injection than those with SCI.
The dose of BOTOX(R) 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(R) 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(R).
Tell your doctor if you have any breathing-related problems. Your doctor may monitor you for breathing problems during treatment with BOTOX(R) 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(R).
Cornea problems have been reported. Cornea (surface of the eye) problems have been reported in some people receiving BOTOX(R) for their blepharospasm, especially in people with certain nerve disorders. BOTOX(R) 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(R). 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(R) for their strabismus. Tell your doctor if you notice any new visual problems while receiving BOTOX(R).
Bronchitis and upper respiratory tract infections (common colds) have been reported. Bronchitis was reported more frequently in adults receiving BOTOX(R) 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(R) for upper limb spasticity, upper respiratory tract infections were reported more frequently. In pediatric patients treated with BOTOX(R) 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 neurologic disease. Autonomic dysreflexia associated with intradetrusor injections of BOTOX(R) 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(R) 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; weakness of forehead muscles; trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; have symptoms of a urinary tract infection (UTI) and are being treated for urinary incontinence (symptoms of a urinary tract infection 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(R) can harm your unborn baby); are breastfeeding or plan to (it is not known if BOTOX(R) 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(R) 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(R) 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(R), Dysport(R), or Xeomin(R) 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(R) include: dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, dry eyes; drooping eyebrows; and upper respiratory tract infection. In adults being treated for urinary incontinence, other side effects include urinary tract infection and painful urination. In children being treated for urinary incontinence, other side effects include urinary tract infection and bacteria in the urine. If you have difficulty fully emptying your bladder on your own after receiving BOTOX(R), 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.
Please see BOTOX(R) full Product Information, including Boxed Warning and Medication Guide.
About UBRELVY(R) (ubrogepant)UBRELVY(R) (ubrogepant) is an orally administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) for the acute treatment of migraine with or without aura in adults that is an option for a wide range of patients who experience migraine attacks. UBRELVY(R) is the first pill of its kind to directly block CGRP, a protein released during a migraine attack, from binding to its receptors.
IMPORTANT SAFETY INFORMATIONWho should not take UBRELVY(R) (ubrogepant)?Do not take UBRELVY(R) if you are taking medicines known as strong CYP3A4 inhibitors, such as ketoconazole, clarithromycin, itraconazole.What should I tell my healthcare provider before taking UBRELVY(R)?Tell your healthcare provider about all your medical conditions, including if you:
-- Have liver problems
-- Have kidney problems
-- Are pregnant or plan to become pregnant
-- Are breastfeeding or plan to breastfeed
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Your healthcare provider can tell you if it is safe to take UBRELVY(R) with other medicines.
What are the most common side effects of UBRELVY(R)?The most common side effects are nausea (4%) and sleepiness (3%). These are not all of the possible side effects of UBRELVY(R).
What is UBRELVY(R) (ubrogepant)?UBRELVY(R) is a prescription medicine used for the acute treatment of migraine attacks with or without aura in adults. UBRELVY(R) is not used to prevent migraine headaches.Please see full Prescribing Information.
About DUOPADUOPA (carbidopa and levodopa) enteral suspension is a prescription medicine used for treatment of advanced Parkinson's disease. DUOPA contains two medicines: carbidopa and levodopa.
Important Safety InformationWhat 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.
Please see the full Prescribing Information including Medication Guide for additional information about DUOPA.
About AbbVie Leadership in MigraineAbbVie, a leader in the migraine space, markets BOTOX(R) (onabotulinumtoxinA), the first FDA-approved, preventive treatment for adults with Chronic Migraine and UBRELVY(R) (ubrogepant), the first FDA-approved oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant), which is indicated for the acute treatment of migraine with or without aura in adults.
About AbbVie in NeuroscienceAt 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 AbbVieAbbVie'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 StatementsSome 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 2020 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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