Merz North America Announces FDA Approval Of XEOMIN® (incobotulinumtoxinA) For Treatment of Adult Upper Limb Spasticity

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Merz North America Announces FDA Approval Of XEOMIN® (incobotulinumtoxinA) For Treatment of Adult Upper Limb Spasticity


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:

  • Talk to your health care provider or pharmacist
  • Visit www.xeomin.com
    to obtain the FDA-approved product labeling
  • Call 1-888-4-XEOMIN

Uses XEOMIN® 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
  • abnormal head position and neck pain in adults with cervical
    dystonia (CD)
  • abnormal spasm of the eyelids (blepharospasm) in adults who have
    had prior treatment with onabotulinumtoxinA (BOTOX®)

 

It is not known whether XEOMIN® is safe or effective in
children.

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 can happen
    within hours to weeks after an injection of
    XEOMIN®
    if the muscles that you use to breathe and swallow become weak.
    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 and may be at greater risk
    for serious breathing problems with XEOMIN®.

 

  • Swallowing problems may last for several months, and during that
    time you 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.

 

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

 

  • 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 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.

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

 

  • 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.”

 

The most common side effects of XEOMIN®
include:

 

  • dry mouth
  • discomfort or pain at the injection site
  • tiredness
  • headache
  • 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, 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.

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.

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.

For more information, please see XEOMIN full Prescribing
Information
and Medication
Guide
.

1 Data on file



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