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Latest News and
Events
FDA Approves Merz Pharmaceuticals’ Xeomin®
(incobotulinumtoxinA) for the
Treatment of Cervical Dystonia and Blepharospasm
GREENSBORO, N.C.,
August 2, 2010 / PRNewswire/ - Merz Pharmaceuticals today
announced that the United States (U.S.) Food and Drug
Administration (FDA) has approved Xeomin®
(incobotulinumtoxinA), a
botulinum toxin type A for the treatment of adults with
cervical dystonia or blepharospasm. According to an
epidemiology study conducted in Rochester Minnesota, the
prevalence of focal dystonia, which includes cervical
dystonia and blepharospasm, is estimated at 295 per million
people in the U.S.
“This is an important
regulatory milestone for XEOMIN and is key to establishing
our neurology business in the U.S.,” said Jack Britts,
President and CEO of Merz Pharmaceuticals, LLC. “We at Merz
understand, and are committed to, addressing the
complexities of treating and living with these neurological
disorders.”
The FDA
approval of XEOMIN is based on the results of two pivotal
U.S. clinical trials involving adult patients diagnosed with
either cervical dystonia or blepharospasm. Additionally,
active comparator studies conducted in Europe evaluating
XEOMIN versus Botox® (onabotulinumtoxinA) were included
among the data submitted in support of the registration
filing in these conditions.
XEOMIN is the only botulinum
toxin that does not require refrigeration prior to
reconstitution. Merz believes this may simplify product
distribution and storage, and help ensure product integrity
at the time of injection. XEOMIN will be available in
50-unit and 100-unit vials allowing dosing flexibility for
administration.
About Dystonia
Dystonias are neurological
movement disorders in which sustained muscle contractions
cause twisting and repetitive movements or abnormal
postures. These movements, which are involuntary and
sometimes painful, may affect a single muscle (focal), a
group of muscles such as those in the arms, legs, or neck
(segmental), or even the entire body (generalized).
Symptoms can be mild or severe and dystonias may be
markedly disabling.
Although dystonia is thought
to be rare, it is possibly undiagnosed or misdiagnosed due
to lack of specific clinical criteria. While focal
dystonia, such as blepharospasm or cervical dystonia, can
affect people at any age, most people first experience
symptoms in middle age.
According to an epidemiology
study conducted in Rochester Minnesota, focal dystonia,
which includes cervical dystonia, and may be characterized
by twisting of the neck, and blepharospasm, or excessive
eyelid spasm is estimated to affect 295 per million people
in the U.S. Dystonias can be disabling, painful and often
interfere with patients’ daily activities.
About XEOMIN
In nature, Clostridium
botulinum produces the toxin in association with ancillary
complexing proteins. Manufacturers utilize this naturally
occurring protein complex to produce therapeutic botulinum
toxin products. Now Merz introduces XEOMIN (incobotulinumtoxinA)
which employs a proprietary manufacturing process that
isolates the therapeutic component and eliminates these
ancillary complexing proteins. XEOMIN has been formulated to
have high biologic activity with a low protein load.
XEOMIN is a botulinum toxin
type A that is free from complexing proteins. It is FDA
approved for the treatment of adults with cervical dystonia,
to decrease the severity of abnormal head position and neck
pain in both botulinum toxin-naïve and previously treated
patients and blepharospasm in adults previously treated with
Botox® (onabotulinumtoxinA). Please see important safety
information below.
More than 84,000 patients
have been treated with XEOMIN worldwide since 2005. The
U.S. is the 20th country to approve XEOMIN for the treatment
of cervical dystonia and blepharospasm.
Important Safety Information
About XEOMIN
WARNING: Distant Spread of
Toxin Effect
The effects of XEOMIN and all
botulinum toxin products may spread from the area of
injection to produce symptoms consistent with botulinum
toxin effects. These symptoms have been reported hours to
weeks after injection. Swallowing and breathing difficulties
can be life threatening and there have been reports of
death. The risk of symptoms is probably greatest in children
treated for spasticity but symptoms can also occur in
adults, particularly in those patients who have underlying
conditions that would predispose them to these symptoms.
See full prescribing information for complete boxed warning.
WARNINGS AND PRECAUTIONS
·
The potency Units of XEOMIN are not
interchangeable with other preparations of botulinum toxin
products. Therefore, units of biological activity of XEOMIN
cannot be compared to or converted into units of any other
botulinum toxin products.
·
Spread of toxin effects
may cause swallowing and breathing difficulties that can
lead to death. Immediate medical attention may be required
in cases of respiratory, speech or swallowing difficulties.
Use with caution in
patients with compromised respiratory function or dysphagia.
Concomitant neuromuscular
disorders may exacerbate clinical effects of treatment.
·
Hypersensitivity reactions have been reported
with botulinum toxin products (anaphylaxis, serum sickness,
urticaria, soft tissue edema, and dyspnea). If serious
and/or immediate hypersensitivity reactions occur, further
injection of XEOMIN should be discontinued and appropriate
medical therapy immediately instituted.
·
Cervical Dystonia: Patients with smaller neck
muscle mass and patients who require bilateral injections
into the sternocleidomastoid muscles are at greater risk of
dysphagia. Limiting the dose injected into the
sternocleidomastoid muscle may decrease the occurrence of
dysphagia.
·
Blepharospasm: Injection of XEOMIN into the
orbicularis oculi muscle may lead to reduced blinking and
corneal exposure with possible ulceration or perforation.
Lower lid injections should not be repeated if diplopia
occurred with previous botulinum toxin injections.
ADVERSE REACTIONS
Cervical Dystonia: The most
commonly observed adverse reactions (≥5% of patients and >
placebo) were: dysphagia, neck pain, muscle weakness,
injection site pain, and musculoskeletal pain.
Blepharospasm: The most
commonly observed adverse reactions (≥5% of patients and >
placebo) were: eyelid ptosis, dry eye, dry mouth, diarrhea,
headache, visual impairment, dyspnea, nasopharyngitis, and
respiratory tract infection.
Please see full prescribing
information for XEOMIN, including Boxed WARNING, available
at
www.merzusa.com.
About Merz
Merz Pharmaceuticals, LLC is a part of Merz,
Inc., a wholly owned U.S. subsidiary of the Merz Group of
Companies and was established in 1995 to develop and
commercialize products for the Merz Group. Areas of
therapeutic focus include Neurology, Dermatology, and
Podiatry along with the #1 non-prescription product for
scars, Mederma®,
and Mederma®
Stretch Marks Therapy.
With a 102 year heritage, Merz (KGaA) is
known worldwide for its development of original compounds
and formulations for medical professionals and consumers in
90 countries. Globally, Merz is a leader in the development
of pharmaceuticals for the treatment of neurological and
psychological disorders as well as for aesthetic medicine.
Global research is concentrated in fields that have a strong
need for therapeutic innovation such as Alzheimer's disease,
Parkinson's disease, tinnitus, chronic pain conditions,
addictions, and neuromuscular disturbances.
SOURCE: Merz Pharmaceuticals
2010 NSTA Symposium
Information
June 25, 2010
The NSTA is hosting
the 21st annually symposium in Baltimore,
Maryland September 11th and 12th, 2010. So what exactly is a
symposium? Who are going to be there? And what could
possibly make you want to go and save these two dates in
your calendar? Well, here is NSTA’s Symposium 101
for all of those wondering minds out there.
Imagine taking a
Spasmodic Torticollis introductory course, condense it down
into about one day—and there you have, the one third of
NSTA’s symposium. Then
you say to yourself, ‘but I could just conveniently obtain
all of the information I need online, from my own comfort
home!’ This is where the other two thirds of the symposium
come in.
Ask yourself, how
often can you find a group of doctors who specialize in
treating Spasmodic Torticollis having coffee together, just
waiting to answer any question you might have for them?
Chances of that happening at your coffee shop are pretty
slim. But no worries, our speakers at the symposium are all
Spasmodic Torticollis experts, they might not be all
drinking coffee at the same time, but the only reason they
are all there is for you. There is a variety of
topics that would be presented at the symposium, from the
very basics of Spasmodic Torticollis—
-
what
makes ST people unique
-
the symptoms, possible causes
-
information on Botox and Botox
Reimbursement
-
Tai chi demonstrations
-
treatments options (physical,
metal, and medication)
-
details on ST surgical
procedures
-
stress management
There will also be
support group meetings and sessions for friends and family.
The best part is, you can ask the specialists any questions
afterwards!
Not everyone who
comes to the symposium has no or little knowledge of this
disorder. Many of you have already researched everything
available there is to know about Spasmodic Torticollis, yet,
you still feel like you were missing something. Here comes
the
last third of our symposium in which you will be playing a
big role in–to help each other filling in the missing piece,
for it is the support that you’ve been craving for
all these years. Coming into the symposium, you’ll be
surrounded by people who would know exactly what you are
going through, have the chance to get advice from those who
have had experience with the treatments you were
considering, or have the opportunity to help others newer to
their diagnosis than yourself to cope. You’d be reminded
that you are not alone. Are you the shy type? Don’t worry,
we have so many events ranging from the city tour, open bar,
to a buffet dinner with entertainments…, there is no way you
could possibly make it through the 2 days without
making new friends!
We will be offering
thirty minute neurofeedback sessions to symposium
registrants. Neurofeedback sessions are limited to
thirty-five available slots so early registration is
recommended.
The symposium site
is the
Marriott Hotel
Baltimore/Washington International Airport
1743 West Nursery
Road,
Baltimore, MD,
21090.
The room rate for
NSTA symposium attendees is only $99.00 for a single or
double occupancy room. The Marriott has a complimentary
shuttle bus service available to bring you from the airport
to the hotel.
Additional
information on the NSTA 21st annually symposium
will be posted periodically.
We look forward to
seeing you there!
Thank You Dixie Carter for Helping us Spread Awareness of
Spasmodic Torticollis
April 10, 2010
Our organization
sends it sincere condolences to the late Dixie Carter’s
husband, Hal Holbrook and the rest of the family. In 2002,
Ms. Carter was so kind to appear in a public service
announcement (PSA) that has spread the awareness of
spasmodic torticollis / cervical dystonia for so many years.
She said “Yes!” when so many celebrities turned us down. She
was so kind to allow us to film the PSA in her Beverly Hills
home so we would not have to secure a location and incur
expenses.
Since January
2009, our PSA have been on rotation on CBS in New York and
New Jersey. On December 2009, the PSA began its run on
Comcast Stations all over the United States. This includes
channels such as TNT, AMC MOVIES, E, CNBC, USA, TLC, CNN,
A&E, ESPN, SPIKE, DISCOVERY, FX, FOX, THE HISTORY CHANNEL,
just to name a few. Since then, we have received over 1850
calls to the NSTA office from people who have symptoms
similar to ST and have not been officially diagnosed or have
been diagnosed and are not aware there is an organization
like NSTA that provides information and support.
Words cannot
express how much it meant to us that she would help a small
organization spread awareness and find people who are
suffering from spasmodic torticollis and are continuously
misdiagnosed. Our thoughts and prayers go out to Hal
Holbrook and the rest of their family during this most
difficult time.
Dystonia Advocacy
Coalition - Department of Defense Announcement
December
21, 2009
The
National Spasmodic Torticollis Association, a proud member
of the Dystonia Advocacy Coalition (DAC), is pleased to
announce the inclusion of dystonia on the list of diseases
eligible for funding through the Congressionally Directed
Medical Research Program. This achievement, reached after
several years of tireless, collaborative efforts by the
advocates of the DAC, now allows for members of the dystonia
research community to apply for funds in support of their
work.
The
Congressional Directed Medical Research Program (CDMRP) is
funded through the Department of Defense via annual
Congressional legislation known as the Department
Appropriations Act (the support is in response to requests
by consumer advocates and disease survivors). CDMRP will
issue a program announcement for 2010 funding opportunities,
including dystonia.
National
Spasmodic Torticollis Association joins with the other DAC
member organizations, the Benign Essential Blepharospasm
Research Foundation, DySTonia, Inc., the Dystonia Medical
Research Foundation, the National Spasmodic Dysphonia
Association, and the National Spasmodic Torticollis
Association, to advocate for all persons affected by
dystonia and supports a legislative and policy agenda that
meets the needs of the dystonia community.
Organizational members of the DAC will now work to promote
this program to the dystonia research community to help
advance dystonia research.
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