ST'r News Articles
Press release
The US-based affiliate of Ipsen announces the launch of Dysport® (abobotulinumtoxinA) in the United States for the treatment of cervical dystonia
Dysport® represents the first new botulinum toxin type A treatment option in eight years to reach the U.S. market place
Brisbane (CA, United States), 29 October 2009 - The US-affiliate of Ipsen (Euronext: FR0010259150; IPN), an innovation-driven global specialty pharmaceutical group, today announced that Dysport® is now available in the United States for the treatment of cervical dystonia in adults.
Dysport® complements the range of Ipsen's drugs already available in North America, both in endocrinology with Somatuline® Depot and Increlex®, and in neurology, with Apokyn®.
"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 29 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-naive 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®.