RALEIGH, N.C.--(BUSINESS WIRE)--Merz Aesthetics, a division of Merz North America (U.S. affiliate of the global Merz Pharma Group), today announced that the medical journal “Dermatologic Surgery“ (Wolters Kluwer) has published data from its post-market, prospective parallel group clinical trial evaluating the efficacy of Xeomin® (incobotulinumtoxinA) in the treatment of moderate to severe glabellar facial lines, when compared to Botox® Cosmetic (onabotulinumtoxinA). The article titled “A Randomized, Double-Blind Trial to Investigate the Equivalence of IncobotulinumtoxinA and OnabotulinumtoxinA for Glabellar Frown Lines“ is now available in the November 2015 issue of the journal.
“Dermatologic Surgery’s publication of this new clinical data demonstrating the efficacy of Xeomin® (incobotulinumtoxinA) will prove critical in encouraging physicians to consider Xeomin® (incobotulinumtoxinA) for their patients as an effective treatment for glabellar lines,“ said Jim Hartman, Vice President and U.S. Head – Merz Aesthetics Injectables. “Merz remains committed to delivering a better total experience in aesthetics, and we are proud to offer patients and physicians a full palette of treatment options across the aesthetic device, injectables and skincare categories.”
Clinical trial results show that this parallel group study met its primary efficacy endpoint of clinical equivalence, defined as ≥ 1-point improvement from baseline on the Facial Wrinkle Scale (FWS) at maximum frown, 1 month after a single treatment. Similar efficacy and tolerability profiles were demonstrated between the two treatment groups at all timepoints (1, 2, 3 and 4 months post-treatment). The most common adverse events seen in both treatment groups were headache, infection and facial asymmetry.
“As the first large, randomized, multicenter direct comparator study to date using the FDA recommended dose of 20 units, this trial represents the definitive U.S. comparison study of Xeomin® (incobotulinumtoxinA) versus Botox® (onabotulinumtoxinA) for the treatment of glabellar facial lines. These study results further confirm the literature demonstrating similar efficacy and safety profiles for both products,“ stated Dr. Michael Kane, MD, co-principal investigator of the study. A board-certified plastic surgeon in private practice in Manhattan, NY, Dr. Kane frequently lectures on topics relating to aesthetic plastic surgery and has published hundreds of papers throughout his career.
Botulinum toxin type A is a well-established treatment for glabellar frown lines. In 2011, Xeomin® (incobotulinumtoxinA) was approved by the FDA for improvement in the appearance of moderate-to-severe glabellar frown lines with a recommended dosage of 20 units (U). Head-to-head comparison studies conducted worldwide have demonstrated that treatment with Xeomin® (incobotulinumtoxinA) and Botox® (onabotulinumtoxinA) result in comparable safety and efficacy for both cosmetic use and therapeutic uses, including blepharospasm and cervical dystonia.1
This manuscript was published in the November 2015 issue of Dermatologic Surgery and is now available online and in print.
About Xeomin® (incobotulinumtoxinA)
XEOMIN® (incobotulinumtoxinA) 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 (glabellar lines) in adults.
About Merz Aesthetics Injectables
Merz Aesthetics 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. In the Injectables category, Merz Aesthetics delivers a strong portfolio of products that is trusted by patients and expert practitioners alike. By providing a palette of options, Merz Aesthetics Injectables seeks to help physicians to focus on choosing and applying technologies that result in the desired outcome for their patients. The Merz Aesthetics Injectables portfolio includes the neurotoxin Xeomin® (incobotulinumtoxinA), the dermal filler Belotero Balance® and the family of Radiesse® products.
To learn more about Merz Aesthetics and their Injectables offerings, please visit www.merzusa.com/aesthetics-otc.
XEOMIN® IMPORTANT SAFETY INFORMATION
Read this Medication Guide before you start receiving XEOMIN® 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:
- Talk to your health care provider or pharmacist
- Visit www.xeominaesthetic.com to obtain the FDA-approved product labeling
- Call 1-866-862-1211
Uses XEOMIN® is a prescription medicine that is injected into muscles and used to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults for a short period of time (temporary).
Warnings
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®:
- Problems with swallowing, speaking, or breathing. These problems can happen hours to weeks after an injection of XEOMIN® if the muscles that you use to breathe and swallow become weak after the injection. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with XEOMIN®.
- People with certain breathing problems may need to use muscles in their neck to help them breathe. These patients may be at greater risk for serious breathing problems with XEOMIN®.
- Swallowing problems may last for several months. People who cannot swallow well may need a feeding tube to receive food and water. If swallowing problems are severe, food or liquids may go into your lungs. People who already have swallowing or breathing problems before receiving XEOMIN® have the highest risk of getting these problems.
-
Spread of toxin effects. In some cases, the effect of botulinum
toxin may affect areas of the body away from the injection site and
cause symptoms of a serious condition called botulism. The symptoms of
botulism include:
- loss of strength and muscle weakness all over the body
- 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
These problems could make it unsafe for you to drive a car or do other dangerous activities.
Active Ingredient
Purpose
incobotulinumtoxinA…………acts on nerve endings in muscles to prevent muscle fibers from contracting
Do not use XEOMIN if you are allergic to XEOMIN® or any of the ingredients in XEOMIN® (see the end of this Medication Guide for a list of ingredients in XEOMIN®), had an allergic reaction to any other botulinum toxin products 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
- have a disease that affects your muscles and nerves (such as amyotrophic lateral sclerosis [ALS or Lou Gehrig's disease], myasthenia gravis or Lambert-Eaton syndrome)
- have allergies to any botulinum toxin product
- have had any side effect from any other botulinum toxin in the past
- have a breathing problem, such as asthma or emphysema
- have a history of swallowing problems or inhaling food or fluid into your lungs (aspiration)
- have bleeding problems
- have drooping eyelids
- have plans to have surgery
- have had surgery on your face
- are pregnant or plan to become pregnant. It is not known if XEOMIN® can harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if XEOMIN® passes into breast milk.
XEOMIN is not recommended for use in children younger than 18 years of age.
Tell your doctor about all of your medical conditions and all of the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements. 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
- have received any other botulinum toxin product in the last four months
- have received injections of botulinum toxin such as rimabotulinumtoxinB (MYOBLOC®), onabotulinumtoxinA (BOTOX®, BOTOX® COSMETIC) and abobotulinumtoxinA (DYSPORT®) in the past. Be sure your doctor knows exactly which product you received. The dose of XEOMIN® may be different from other botulinum toxin products that you have received.
- have recently received an antibiotic by injection
- take muscle relaxants
- take an allergy or cold medicine
- take a sleep medicine
- take a blood thinner medicine
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.”
Headache was the most common side effect of XEOMIN for treatment of glabellar lines. Other possible side effects include:
- dry mouth
- discomfort or pain at the injection site
- tiredness
- neck pain
- muscle weakness
- eye problems, including: double vision, blurred vision, drooping eyelids, swelling of your eyelids, and dry eyes. Reduced blinking can also occur. Tell your doctor or get medical help right away if you have eye pain or irritation following treatment.
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, or dizziness or feeling faint. Tell your doctor or get medical help right away if you get wheezing or asthma symptoms, or if you get dizzy or faint.
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of XEOMIN®. For more information, talk to your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Directions
- XEOMIN® is a shot (injection) that your doctor will give you.
- XEOMIN® is injected into your affected muscles.
- Your doctor may change your dose of XEOMIN® until you and your doctor find the best dose for you.
Inactive Ingredients human albumin and sucrose
XEOMIN and BELOTERO are registered trademarks and Merz Aesthetics is a registered trademark of Merz Pharma GmbH & Co. KGaA. RADIESSE is a registered trademark of Merz North America, Inc.
Botox®, Dysport® and Myobloc® are registered trademarks of their respective owners.
1 Data on file
