RALEIGH, N.C.--(BUSINESS WIRE)--Merz North America, U.S. affiliate of the global Merz Pharma Group, announces that Xeomin® (incobotulinumtoxinA) has received U.S. FDA approval for the treatment of upper limb spasticity (ULS) in adult patients. In clinical studies, treatment with Xeomin® (incobotulinumtoxinA) for adult ULS resulted in statistically and clinically significant improvements in muscle tone, with a safety profile similar to that observed for other Xeomin® (incobotulinumtoxinA) indications.
“We know that each patient has unique needs, and this new indication for Xeomin® (incobotulinumtoxinA) is a result of our long-term commitment to serving individuals living with movement disorders and spasticity,“ said Glenn Block, Vice President and Head – US Neurosciences for Merz North America. “We look forward to supporting the launch of Xeomin® for adult upper-limb spasticity with forward-thinking strategies in product support, clinical education, and patient advocacy and engagement.“
Xeomin® (incobotulinumtoxinA) was first approved by the U.S. FDA in August 2010 for the treatment of adults with cervical dystonia and blepharospasm. Today, Xeomin® (incobotulinumtoxinA) is available in 43 countries across the globe. Over one million patients worldwide have been treated with Xeomin® (incobotulinumtoxinA)1.
“In multiple well-controlled clinical trials, treatment of adult ULS with Xeomin® (incobotulinumtoxinA) resulted in significant improvements in muscle tone,“ said David M. Simpson, MD, FAAN, Professor of Neurology at The Icahn School of Medicine at Mount Sinai, Department of Neurology. “The addition of this effective treatment option for adult ULS means that U.S. physicians now have greater flexibility in selecting a neurotoxin therapy that meets the needs of their individual patients.”
Dr. David M. Simpson is Director of the Neuromuscular Diseases Division and Clinical Neurophysiology Laboratories at The Icahn School of Medicine at Mount Sinai. Dr. Simpson is a member of the American Neurological Association and the American Pain Society. He is a Fellow of the American Academy of Neurology and the American Academy of Neuromuscular and Electrodiagnostic Medicine.
“Merz North America remains dedicated to pursuing strategic, targeted research and development programs in the neurosciences space, with the ultimate goal of providing meaningful treatment options for movement disorder and spasticity patients,“ said David Dobrowski, Vice President and Head of Research and Development for Merz North America.
The safety and efficacy of Xeomin® (incobotulinumtoxinA) in the treatment of adult upper limb spasticity was evaluated in multiple Phase III clinical studies in more than 400 patients with ULS. The approval of Xeomin® (incobotulinumtoxinA) for the treatment of adult ULS is based on results of a randomized, multicenter, placebo-controlled trial showing significant improvements in two co-primary outcome parameters: muscle tone (Ashworth Scale score) and the Investigator’s Global Impression of Change of the Primary Target Clinical Pattern (PTCP) at Week 4. Both showed statistical significance, with p < 0.001 and p = 0.003 respectively. The trial also met a key secondary outcome measure, in which subjects with an improvement ≥1 on the Ashworth Scale at Week 4 were classified as responders (p<0.001). Treatment related adverse events were reported for 3.8% and 1.9% of subjects treated with Xeomin® (incobotulinumtoxinA) and placebo, respectively. The most commonly observed adverse reactions (incidence ≥2% of patients and greater than placebo) for Xeomin® were seizure (3%), nasopharyngitis (2%), dry mouth (2%), and upper respiratory tract infection (2%).
About XEOMIN® (incobotulinumtoxinA)
Xeomin® (incobotulinumtoxinA) is a prescription medicine that is injected into muscles and used to treat increased muscle stiffness in the arm of adults with upper limb spasticity, the abnormal head position and neck pain that happens with cervical dystonia (CD) in adults, and to treat abnormal spasm of the eyelids (blepharospasm) in adults who have had prior treatment with onabotulinumtoxinA (Botox®).
About Merz Neurosciences
Merz Neurosciences is a division of Merz North America, a specialty healthcare company that is dedicated to delivering a better total experience in aesthetics, dermatology and neurosciences. By working side by side with physicians and patients, Merz Neurosciences strives to deliver meaningful treatment options and a better patient experience in order to meet the needs of each person we serve. Merz Neurosciences is an important contributor to the U.S. neurosciences space, offering a well-balanced product portfolio that includes the neurotoxin Xeomin® (incobotulinumtoxinA), the anticholinergic Cuvposa™ (glycopyrrolate) Oral Solution and the Prolaryn™ family of products.
To learn more about Merz Neurosciences and their U.S. product portfolio, please visit www.merzusa.com/neurosciences.
XEOMIN® IMPORTANT CONSUMER SAFETY INFORMATION
Read the Medication Guide before you start receiving XEOMIN® (Zeo-min) and each time XEOMIN® is given to you as there may be new information. The risk information provided here is not comprehensive. To learn more:
Uses XEOMIN® is a prescription medicine that is injected into muscles and used to treat:
It is not known whether XEOMIN® is safe or effective in children.
XEOMIN® may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems anytime (hours to week) after treatment with XEOMIN®:
These problems could make it unsafe for you to drive a car or do other dangerous activities.
Do not take XEOMIN® if you: are allergic to XEOMIN® or any of the ingredients in XEOMIN® (see the end of this Guide for a list of ingredients in XEOMIN®), had an allergic reaction to any other botulinum toxin product such as rimabotulinumtoxinB (Myobloc®), onabotulinumtoxinA (Botox®, Botox® Cosmetic), or abobotulinumtoxinA (Dysport®) or have a skin infection at the planned injection site.
Ask a doctor before use if you
Tell your doctor about all of your medical conditions and all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Using XEOMIN® 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 XEOMIN in the past.
Especially tell your doctor if you
Ask your doctor if you are not sure if your medicine is one that is listed above.
Possible Side Effects
XEOMIN® can cause serious side effects that can be life threatening. See “Warnings.”
The most common side effects of XEOMIN® include:
XEOMIN® may cause other serious side effects including allergic reactions. Symptoms of an allergic reaction to XEOMIN® may include: itching, rash, redness, swelling, wheezing, asthma symptoms, dizziness or feeling faint. Tell your doctor or get medical help right away if you have wheezing or asthma symptoms, or if you get dizzy or faint.
These are not all the possible side effects of XEOMIN®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of XEOMIN
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use XEOMIN for a condition for which it was not prescribed. Do not give XEOMIN to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or doctor for information about XEOMIN that is written for health professionals.
Active Ingredient: incobotulinumtoxinA
Inactive Ingredients: human albumin and sucrose
Copyright © 2015 Merz North America, Inc. All rights reserved. XEOMIN is a registered trademark of Merz Pharma GmbH & Co. KGaA. BOTOX is a registered trademark of Allergan, Inc. DYSPORT is a registered trademark of Ipsen Biopharm Limited Company. MYOBLOC is a registered trademark of Solstice Neurosciences, Inc.
1 Data on file