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- Allergan Aesthetics and Allergan, an ABBVie company (NYSE: ABBV), announced today that scientific and clinical experts in the field of neurotoxins will present results from 16 abstracts spanning pre-clinical and clinical studies evaluating key safety and efficacy of BOTOX® (onabotulinumtoxinA) across multiple therapeutic and cosmetic indications. Data includes long-term immunogenicity rates across 10 therapeutic and aesthetic indications, analyses from the Adult Spasticity International Registry (ASPIRE) study and Cervical Dystonia Patient Registry for BOTOX® Efficacy (CD-PROBE), reviewing adherence to onabotulinumtoxinA treatment in patients with spasticity and efficacy and tolerability in patients with cervical dystonia, respectively. Also to be presented are data on incontinence product use and associated costs in patients with overactive bladder treated with onabotulinumtoxinA. Additionally, results from a randomized controlled clinical trial on the efficacy and safety of three active doses of onabotulinumtoxinA for the treatment of neurogenic detrusor overactivity in children and findings from a study on the safety, pharmacodynamic response and treatment satisfaction, with increasing doses of onabotulinumtoxinA in patients with moderate to severe dynamic glabellar lines will be presented. These data will be presented at the TOXINS 2021 Virtual Conference, organized by The International Neurotoxin Association (INA), January 16-17 .
"We continue to be deeply committed to advancing research of neurotoxins and are pleased to be able to share the depth and breadth of our latest data on BOTOX® and BOTOX® Cosmetic at the TOXINS 2021 Virtual Conference," said Mitchell F. Brin, M.D., Senior Vice President, Chief Scientific Officer, BOTOX® & Neurotoxins, AbbVie. "With over 30 years in the neurotoxin space, we are excited to further build on this heritage as part of AbbVie. It allows us to support health professionals in meeting the individual needs of patients around the world on an even greater scale, both now and in the future."
The abstracts are expected to be published online in a supplement of the journal Toxicon on January 16, 2021 with open access for six months after the conference. They will also be presented virtually over the course of the two-day conference.
The TOXINS 2021 Virtual Poster Hall opens on January 16 and will remain open to conference attendees for 60 days post-conference. AbbVie abstracts being presented at the conference are outlined below.
Adherence to OnabotulinumtoxinA Treatment in Patients with Spasticity from the ASPIRE Study |
Sustained Efficacy and Tolerability of OnabotulinumtoxinA in Naive and Non-naive Patients with Cervical Dystonia: Preliminary Completer Analysis from CD-PROBE |
Reduction in Incontinence Product Use and Associated Cost Savings After OnabotulinumtoxinA Treatment in Patients with Overactive Bladder |
Lower Limb Injections of OnabotulinumtoxinA: Improvement in Gait and Treatment Goal Achievement in Pediatric Patients with Cerebral Palsy |
Efficacy and Safety of an Alternative OnabotulinumtoxinA Injection Paradigm for Overactive Bladder: Final Double-Blind and Open-Label Results in Female Patients |
Efficacy and Safety of Three Active Doses of OnabotulinumtoxinA for the Treatment of Neurogenic Detrusor Overactivity in Children: Results of a Randomized Controlled Clinical Trial |
Real-life Use of OnabotulinumtoxinA for Symptom Relief in Patients with Chronic Migraine: REPOSE Study German Population |
Safety, Pharmacodynamic Response, and Treatment Satisfaction with OnabotulinumtoxinA 40 U, 60 U, and 80 U in Subjects with Moderate to Severe Dynamic Glabellar Lines |
Safety and Efficacy of OnabotulinumtoxinA for Treatment of Masseter Muscle Hypertrophy: Results from a Phase 2 Dose-Escalation Study |
Pregnancy Outcomes Following Exposure to OnabotulinumtoxinA Update: 29 Years of Safety Observation |
OnabotulinumtoxinA (OnabotA) Exhibits Greater Efficacy Compared with Purified Botulinum Neurotoxin A (BoNT/A-150 kDa) in Peripheral Pain Models |
Greater Biological Activity of OnabotulinumtoxinA and Non-interchangeability with Vacuum-Dried PrabotulinumtoxinA |
Botulax displays lower enzymatic activity when compared to onabotulinumtoxinA in a light chain activity assay |
A Cell-Penetrating Peptide (CPP) Did Not Decrease 150-kDa BoNT/A Toxin Adsorption to Surfaces or Increase Toxin Potency or Duration in a Prototype Formulation |
Neutralizing Antibody Conversion with OnabotulinumtoxinA from Global Studies Across Multiple Indications in Nearly 30,000 Patient Records: A Meta-Analysis |
Engineering SNAP23 Specificity into the Highly Selective C lostridium Botulinum Protease |
About BOTOX ®
BOTOX ® (onabotulinumtoxinA) U.S. Important Information
IMPORTANT SAFETY INFORMATION
BOTOX ® and BOTOX ® Cosmetic 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 ® or
BOTOX ® Cosmetic:
- 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® has been used at the recommended dose to treat chronic migraine, severe underarm sweating, blepharospasm, strabismus, or when BOTOX® Cosmetic has been used at the recommended dose to treat frown lines, crow's feet lines, and/or forehead lines.
Indications
BOTOX® is a prescription medicine that is injected into specific 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 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 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.
BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe forehead lines, crow's feet lines, and frown lines between the eyebrows in adults.
It is not known whether BOTOX® and BOTOX® Cosmetic are safe or 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® and BOTOX® Cosmetic are safe or effective for severe sweating anywhere other than your armpits.
It is not known if BOTOX® Cosmetic is safe or effective for use more than 1 time every 3 months.
IMPORTANT SAFETY INFORMATION (continued)
BOTOX® and BOTOX® Cosmetic may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX® or BOTOX® Cosmetic. If this happens, do not drive, operate machinery, or do other dangerous activities.
Do not receive BOTOX ® or BOTOX ® Cosmetic if you: are allergic to any of its ingredients (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 (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® compared to 2 of the 542 treated with placebo. The median duration of post-injection 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.
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® 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® 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 ® and BOTOX ® Cosmetic is not the same as, or comparable to, any other 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® or BOTOX® Cosmetic should be discontinued.
Tell your doctor about all your muscle or nerve conditions, such as amyotrophic lateral sclerosis (ALS) also known as 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® or BOTOX® Cosmetic.
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 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 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; 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® or BOTOX® Cosmetic can harm your unborn baby); are breastfeeding or plan to (it is not known if BOTOX® or BOTOX® Cosmetic 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® or BOTOX® Cosmetic 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 ® or BOTOX ® Cosmetic in the past.
Tell your doctor if you have 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 ® and BOTOX ® Cosmetic 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 people being treated for urinary incontinence other side effects include urinary tract infection, painful urination, and/or inability to empty your bladder on your own. If you have difficulty fully emptying your bladder 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.
Please see BOTOX ® full Product Information , including Boxed Warning and Medication Guide .
Please see BOTOX ® Cosmetic full Product Information , including Boxed Warning and Medication Guide
Globally, prescribing information varies; refer to the individual country product label for complete information.
About Allergan Aesthetics
Allergan Aesthetics, an AbbVie company, develops, manufactures, and markets a portfolio of leading aesthetics brands and products. Their aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Their goal is to consistently provide customers worldwide with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. www.AllerganAesthetics.com
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 disorder and depression, major depressive disorder, migraine, multiple sclerosis, Parkinson's disease, spinal cord injuries, post-stroke spasticity, schizophrenia, and stroke.
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. For more information, please visit www.abbvie.com .
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 2019 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.
SOURCE AbbVie
