DUBLIN, Dec. 16, 2019 /PRNewswire/ -- Allergan plc (NYSE: AGN) is commemorating today the beginning of the 30th anniversary celebration for BOTOX® this year with the ringing of the New York Stock Exchange opening bell. Over the past 30 years, more than 100 million vials of BOTOX® and BOTOX® Cosmetic have been manufactured worldwide, providing a trusted and effective treatment option for various therapeutic and aesthetic uses. With two additional U.S. Food and Drug Administration (FDA) approvals this year for therapeutic indications of pediatric upper limb spasticity and pediatric lower limb spasticity, excluding spasticity caused by cerebral palsy, BOTOX® and BOTOX® Cosmetic now proudly hold 14 therapeutic and aesthetic indications combined, reinforcing its leadership in neurotoxin science.
"This incredible milestone underscores our constant focus on innovation and motivates us to further build on our 30 years of research and development efforts for BOTOX®," said Mitchell F. Brin, M.D., Senior Vice President Global Drug Development, Chief Scientific Officer, BOTOX® & Neurotoxins. "For three decades, our team has been dedicated to manufacturing and delivering BOTOX® from an unparalleled state-of-the-art facility, abiding to the strictest quality and safety standards. As we now look forward to the next 30 years and beyond, we maintain our commitment to serve patients worldwide across a wide spectrum of diseases and clinical needs."
BOTOX® was first FDA-approved in 1989 for two rare eye muscle disorders – blepharospasm and strabismus in adults, making it the world's first botulinum toxin type A product to be approved. Since then, BOTOX® has continued to innovate which has led to the FDA's approval of 11 therapeutic indications, including Chronic Migraine, overactive bladder, leakage of urine (incontinence) associated with a neurologic condition, cervical dystonia, adult upper limb spasticity, adult lower limb spasticity, severe underarm sweating (axillary hyperhidrosis), and most recently, pediatric upper limb spasticity and pediatric lower limb spasticity, excluding spasticity caused by cerebral palsy. Allergan remains committed to pioneering research and development efforts to continue leading innovation in neurotoxins, and to providing robust resources and services to ensure BOTOX® is accessible and affordable to patients, including the BOTOX® Savings Program.
"Our ongoing collaboration with Allergan and the approval of BOTOX® in 2000 as a first-line treatment for cervical dystonia have been very important to us and have brought hope to the cervical dystonia community," said Art Kessler, President of the Board, Dystonia Medical Research Foundation (DMRF). "We value our shared commitment to raising awareness of the disease, potential treatment options, and the importance of talking to your doctor."
As the first neurotoxin treatment to be approved for aesthetic use, BOTOX® Cosmetic remains a category leader, backed by 17 years of data. Receiving its first FDA approval in 2002 to temporarily improve the appearance of moderate to severe glabellar lines (frown lines between the eyebrows), BOTOX® Cosmetic is also approved for the temporary improvement in the appearance of moderate to severe crow's feet and forehead lines in adults.
With more than 3,900 articles on BOTOX® and BOTOX® Cosmetic published in scientific and medical journals, and over 115 sponsored studies, BOTOX® neurotoxin is one of the most widely researched medicines in the world. BOTOX® continues to be a leader in its category as it carries 28 indications worldwide, with approval for use in 100 different countries. Backed by strong science and a global presence, BOTOX® proudly embraces its past while boldly looking to the future. Learn more at BOTOXEndlessInnovation.com.
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 muscles and used:
To treat overactive bladder symptoms such as a strong need to urinate with leaking or wetting accidents, a strong need to urinate right away, and urinating often 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 elbow, wrist, finger, thumb, ankle, and toe muscles in people 18 years and older with upper and lower limb spasticity
To treat increased muscle stiffness in children 2 to 17 years of age with upper limb spasticity
To treat increased muscle stiffness in children 2 to 17 years of age with lower limb spasticity, excluding spasticity caused by cerebral palsy
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 frown lines between the eyebrows, crow's feet lines, and forehead lines 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).
It is not known whether BOTOX® is safe or effective to treat increased stiffness in upper limb muscles other than those in the elbow, wrist, fingers, and thumb, or in lower limb muscles other than those in the ankle and toes in people 18 years and older. 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 other types of muscle spasms or 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® and BOTOX® Cosmetic. If this happens, do not drive a car, 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. 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, or 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 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® 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 adult 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 infection was not reported with an incidence greater 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 havereceived 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 injection; take muscle relaxants; take allergy or cold medicines; take sleep medicine; take aspirin-like products or blood thinners.
Other side effects of BOTOX® and BOTOX® Cosmetic include: dry mouth, discomfort or pain at 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.
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a global pharmaceutical leader focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world. Allergan markets a portfolio of leading brands and best-in-class products primarily focused on four key therapeutic areas including medical aesthetics, eye care, central nervous system and gastroenterology. As part of its approach to delivering innovation for better patient care, Allergan has built one of the broadest pharmaceutical and device research and development pipelines in the industry.
With colleagues and commercial operations located in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective on existing trends and information as of the date of this release. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; the impact of uncertainty around timing of generic entry related to key products, including RESTASIS®, on our financial results; risks associated with divestitures, acquisitions, mergers and joint ventures; risks related to impairments; uncertainty associated with financial projections, projected cost reductions, projected debt reduction, projected synergies, restructurings, increased costs, and adverse tax consequences; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2018 and Allergan's Quarterly Report on Form 10-Q for the period ended September 30, 2019. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.