Dysport® represents the first new botulinum toxin type A treatment option in eight years to reach the U.S. market place
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(HealthNewsDigest.com) – Brisbane (CA, United States), – The US-affiliate of Ipsen (Euronext: FR0010259150; IPN), today announced that Dysport® is now available in the United States for the treatment of cervical dystonia in adults.
“With the launch of Dysport®, physicians have an important treatment option for their patients suffering from cervical dystonia,” said Matthew Brodsky, M.D., assistant professor of neurology and director of the Neurotoxin Injection Program of the Movement Disorders Program and Parkinson Center of Oregon Health & Science University. “Data from two large clinical studies, support the safety and efficacy of using Dysport® to manage the severity of neck pain and abnormal head position often associated with cervical dystonia,” said Dr. Brodsky, who served as a clinical investigator in the first U.S. pivotal study of Dysport®.
“Ipsen is committed to working with the dystonia community, including both patients and physicians, to ensure that people have appropriate access to Dysport® and to provide comprehensive education about the potential benefits and side effects of Dysport® for the treatment of cervical dystonia” said Jean P. Hubble, M.D., vice president of Medical Affairs, Neurology, at Ipsen’s U.S. affiliate.
About Dysport® (abobotulinumtoxinA)
Dysport® (abobotulinumtoxinA) inhibits release of the neurotransmitter acetylcholine from peripheral cholinergic nerve endings, which reduces muscular spasm. The active ingredient in Dysport® is a botulinum toxin type A, which acts at the level of the neuromuscular junction in the targeted muscle. Dysport® inhibits release of the neurotransmitter acetylcholine from peripheral cholinergic nerve endings, which reduces muscular spasm. Used in patient care in the United Kingdom since 1991, Dysport™ has marketing authorizations in 75 countries (as of 31 December 2008) for multiple therapeutic uses. Patient exposure is estimated to be above two million single treatment cycles, representing more than 840,000 patient years of treatment.
Dysport® was approved by the Food and Drug Administration on 28 April 2009 for two separate indications, the treatment of cervical dystonia to reduce the severity of abnormal head position and neck pain in both toxin-naïve and previously treated patients, and the temporary improvement in the appearance of moderate to severe glabellar lines in adults younger than 65 years of age. Ipsen will market DYSPORT® in the United States for the therapeutic indication (cervical dystonia), while Medicis already markets DYSPORT® in the U.S. for the aesthetic indication (glabellar lines).
To help streamline access to Dysport®, Ipsen has developed a comprehensive reimbursement program that provides comprehensive access and support for U.S. patients and healthcare providers. The program, called PACE (Patient Access, Care and Education), offers a customer service call center (888-525-2423) to assist people seeking information about Dysport®.
Boxed Warning for All Botulinum Toxin Products
On April 30, 2009, the U.S. Food and Drug Administration announced that safety label changes, including a boxed warning, and a Risk Evaluation and Mitigation Strategy (REMS), are necessary for all botulinum toxin products.
About the Risk Evaluation and Mitigation Strategy (REMS) for Dysport®
DYSPORT® is differentiated from other marketed botulinum toxin products with the unique name abobotulinumtoxinA.
Ipsen has implemented a REMS in order to ensure that the potential benefits of treating cervical dystonia with Dysport® outweigh the potential risks of:
Medication errors related to the lack of interchangeability of Dysport® Units with those of toxins of other manufacturers; and
The potential for the occurrence of spread of toxin effect beyond the injection site
A key element of the Dysport® REMS is an FDA-approved patient Medication Guide, which will be provided with each carton of Dysport®. The physician should provide a copy of the Medication Guide to each patient and review the contents with the patient. By promoting an informed discussion between the physician and patient, the Medication Guide will help ensure that patients are fully aware of and understand the risks of Dysport® treatment in relation to the potential benefits.
Important Safety Information About Dysport®
The effects of Dysport® 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. Immediate medical attention may be required in cases of respiratory, speech or swallowing difficulties.
Dysport® is contraindicated in patients with hypersensitivity to any botulinum toxin product or excipients, allergy to cow’s-milk protein, or infection at the proposed injection site. The potency units of Dysport® are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of Dysport® cannot be compared to or converted into units of any other botulinum toxin products assessed with any other specific assay method. Concomitant neuromuscular disorder may exacerbate clinical effects of treatment. Patients receiving concomitant treatment of Dysport® and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like agents), or muscle relaxants, should be observed closely because the effect of botulinum toxin may be potentiated.
The most commonly reported adverse reactions (>5% of patients) observed with Dysport™ for the treatment of cervical dystonia are muscular weakness, dysphagia, dysphonia, dry mouth, injection site discomfort or pain, fatigue, headache, neck pain, musculoskeletal pain, dysphonia, injection site pain and eye disorders. Visit www.Dysport.com to see the full Prescribing Information, including Boxed Warning and Medication Guide, as well as the PACE program.
About Cervical Dystonia
Cervical dystonia is an orphan condition in the U.S. affecting approximately 125,000 people.1 It is a chronic and painful condition characterized by neck muscles contracting involuntarily, which causes abnormal movements and awkward posture of the head and neck. Symptoms usually begin in people age 40 years or older, and women are more commonly affected by the condition than men.2
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