DUBLIN, Jan. 22, 2016 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company today announced that the U.S. Food and Drug Administration (FDA) has approved BOTOX® (onabotulinumtoxinA) for the treatment of lower limb spasticity in adult patients to decrease the severity of increased muscle stiffness in ankle and toe muscles. BOTOX® is the first and only botulinum toxin product to be approved by the FDA to treat multiple muscle groups of the upper (elbow, wrist, fingers, and thumb) and lower limbs that may be impacted by spasticity.
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BOTOX® was first approved for the treatment of upper limb spasticity (ULS), or increased muscle stiffness in the elbow, wrist and fingers, in adults in March 2010. Additional FDA approval was received in April 2015 to expand the BOTOX® label for the treatment of adults with ULS to include the addition of two thumb muscles. 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 to treat increased stiffness in lower limb muscles other than those in the ankle and toes. 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. Treatment with BOTOX® is not meant to replace your existing physical therapy or other rehabilitation that your doctor may have prescribed.
"Spasticity is a debilitating condition that can have a significant impact on patients' lives, compromising their ability to perform a range of daily activities," said Mitchell F. Brin, M.D., Senior Vice President Global Development and Scientific Officer, BOTOX®. "This FDA approval marks our continued commitment to partnering with scientists and researchers around the world to explore the potential benefits of BOTOX® in treating specific medical conditions. We are pleased that through this research, we are now able to offer this treatment option for patients with lower limb spasticity."
Spasticity is a condition in which there is an abnormal increase in muscle tone or stiffness of muscle, which may interfere with movement, or be associated with discomfort.[i] Affecting approximately 1 million people in the U.S., spasticity is usually caused by damage to the portion of the brain or spinal cord that controls voluntary movement.[ii] The most common causes of spasticity include stroke, adult cerebral palsy, multiple sclerosis, traumatic brain injury, spinal cord injury, physical trauma, or infection.ii
"In my experience, stroke survivors are among the most prominent groups to be impacted by spasticity affecting the upper and lower limbs; and it is critical to continue seeking treatment from a physician specially trained to manage spasticity," said Alberto Esquenazi, M.D., John Otto Haas Chair and Professor, Department of Physical Medicine and Rehabilitation; Director, Gait & Motion Analysis Laboratory, MossRehab, and a lead investigator in the studies. "The results reinforce the efficacy and safety of BOTOX®, and physicians can now have even greater confidence when offering their patients another approach to treating these specific muscles."
The FDA approval was based on a large, international development program that included a phase three, multi-center, double-blind, randomized, placebo-controlled clinical trial that evaluated the safety and efficacy of BOTOX® compared to placebo in more than 400 patients with lower limb spasticity following stroke. The study compared a total BOTOX® dose of 300 to 400 units divided among ankle and toe muscles (n=233) to placebo (n=235). Statistically significant improvements were observed in the two co-primary endpoints of average change from baseline in the improvement of muscle tone measured by the Modified Ashworth Scale (MAS) ankle score and the clinical benefit for patients as assessed by the Clinical Global Impression of Change by Physician (CGI) at weeks 4 and 6 (p<0.05). The most frequently reported adverse reactions (>2%) were arthralgia (3%), back pain (3%), myalgia (2%), upper respiratory tract infection (2%) and injection site pain (2%). The safety profile observed in the study was consistent with the known safety profile of BOTOX®.
BOTOX® (onabotulinumtoxinA) is a prescription medicine that is injected into muscles and used 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.
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 to treat increased stiffness in lower limb muscles other than those in the ankle and toes. 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. Treatment with BOTOX® is not meant to replace your existing physical therapy or other rehabilitation that your doctor may have prescribed.
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 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, trouble swallowing.
BOTOX® may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX®. If this happens, do not drive a car, operate machinery, or do other dangerous activities.
Do not take 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.
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. They include 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® 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 will want to monitor you for any breathing problems during your treatment with BOTOX® for spasticity. The risk of pulmonary effects in patients with compromised respiratory status is increased in patients receiving BOTOX®.
Bronchitis and upper respiratory tract infections (common colds) have been reported. Bronchitis was reported more frequently in people receiving BOTOX® for upper limb spasticity. Upper respiratory infections (common colds) were also reported more frequently in people with prior breathing-related problems with upper and lower limb spasticity.
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; 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 nonprescription medicines, vitamins, and herbal products. 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: 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® include: dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes.
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.
® marks owned by Allergan, Inc.
Myobloc® is a registered trademark of Solstice Neuroscience, Inc.
Dysport® is a registered trademark of Ipsen Biopharm, Ltd.
Xeomin® is a registered trademark of Merz Pharma Gmbh & Co.
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women's health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world's third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Allergan is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.
With commercial operations 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.
For more information, visit Allergan's website at www.allergan.com.
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 of existing trends and information as of the date of this release. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. 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; 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2015 (such periodic public filings having been filed under the "Actavis plc" name). Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.
[i] NINDS Spasticity Information Page. National Institute of Neurological Disorders and Stroke. Available at http://www.ninds.nih.gov/disorders/spasticity/spasticity.htm. Accessed November 23, 2015
[ii] Data on File, Allergan, Inc. Global Safety and Epidemiology: Spasticity and comorbidity following five disorders: stroke, multiple sclerosis, spinal cord injury, traumatic brain injury, and cerebral palsy in adults, 2009.
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