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Published on: 5/4/2009
Last Visited: 5/22/2009
"One of the advantages of BOTOX(R) therapy is its highly selective mechanism of action and targeted mode of administration, via injection directly into the affected muscle or gland, which in large part explains the product's clinical performance and predictable patient outcomes," explained Mitchell F. Brin, M.D., Allergan's Senior Vice President of Global Development and Chief Scientific Officer for BOTOX(R).
No Two Botulinum Toxins Are Alike
With additional botulinum toxin products awaiting FDA approval, Dr. Brin reviewed the scientific differences among botulinum toxin therapies and the factors that physicians and patients should weigh when considering treatment options.
"The well-established risk/benefit profile of BOTOX(R) is unique to the product, because no two botulinum toxins are alike," said Dr. Brin.
He pointed out that botulinum toxin products are biologics - i.e., derived from living substances, in this case, from the Clostridium botulinum bacteria.
This bacteria produces seven different subtypes of botulinum toxin, with type A being the most potent.
Differences among subtypes may influence therapeutic effects and how long they last, or the occurrence of adverse events following treatment.
Even among botulinum toxin products of the same subtype, variations in manufacturing processes can result in differences in the product's characteristics, including formulation (e.g., molecular uniformity and weights of toxin complexes), pharmacokinetics, and clinical parameters such as efficacy, duration of effect, risk/benefit profile and immunogenicity.
"Because of these differences, each botulinum toxin also has distinct dosing requirements," said Dr. Brin.
"Importantly for physicians and patients, this means that BOTOX(R) is not interchangeable with other botulinum toxins and a physician cannot simply use a fixed-dose ratio and expect the same precise and predictable results."
The Patient and Physician Experience
While practicing in the 1980s at Columbia-Presbyterian Medical Center in New York City, Dr. Brin, a neurologist, co-led one of the first clinical trials of BOTOX(R) (Botulinum Toxin Type A) as a treatment for cervical dystonia supported by the Food and Drug Administration's Office of Orphan Product Development, when a young man named Tom Stampe was referred to him.
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After years of misdiagnosis and disability, I was finally referred to Dr. Brin who diagnosed my condition as cervical dystonia.