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National Spasmodic Torticollis Association
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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.
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—
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- 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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