Happy 20th BOTOX

Allergan, Inc. Marks 20 Years Since the First Approved Indications by the U.S. Food and Drug Administration for BOTOX(R) (Botulinum Toxin Type A)

IRVINE, Calif./PRNewswire-FirstCall via COMTEX News Network/ — As part of the nearly 20-year milestone since the first approved indications by the U.S. Food and Drug Administration (FDA) for BOTOX(R) (Botulinum Toxin Type A), Allergan, Inc. (NYSE: AGN), the maker of BOTOX(R) and BOTOX(R) Cosmetic, conducted a Web-based media briefing that provided an in-depth review of the evolution and science of BOTOX(R) therapy, its risk/benefit profile and how to evaluate the differences between botulinum toxin therapies. Perspectives on these topics were provided by leading researchers and Allergan scientists, and by patients who discussed their treatment with BOTOX(R) and BOTOX(R) Cosmetic.

It has been nearly 20 years since BOTOX(R) was first approved by the FDA to treat two specific eye muscle disorders. Since 1989, the FDA has approved two additional therapeutic indications for BOTOX(R) and one aesthetic indication, using the same formulation and under the name BOTOX(R) Cosmetic (Botulinum Toxin Type A), with dosing specific to temporarily treat moderate to severe glabellar lines in people ages 18 to 65. To date, BOTOX(R) is approved for 20 different therapeutic indications in approximately 80 countries worldwide. BOTOX(R) Cosmetic is authorized for aesthetic treatment in approximately 60 countries.

“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.
“I was 23 years old, and I started getting this very bad neck pain,” said Mr. Stampe. “One day the neck pain started making me go into a twitch and my head started pulling to one side to the point that it stayed stuck on my right shoulder. For three years I couldn’t move it, couldn’t turn it, couldn’t do anything. After years of misdiagnosis and disability, I was finally referred to Dr. Brin who diagnosed my condition as cervical dystonia. At that time they were trying out a new investigational drug, and he thought I’d be a very good candidate for it. It was BOTOX(R). Shortly after those first injections my head and neck began to move freely, and it’s a feeling I’ll never forget.” Today, Mr. Stampe is an advocate for cervical dystonia patients and currently serves as President of the New York chapter of the Dystonia Medical Research Foundation.
“The clinical development of BOTOX(R) (Botulinum Toxin Type A) has improved the management of a number of disabling conditions characterized by excessive muscle or glandular activity, and just as importantly for patients like Mr. Stampe, it has expanded interest in their diagnosis and treatment,” said Joseph Jankovic, M.D., Professor of Neurology, Distinguished Chair in Movement Disorders, and Director of the Parkinson’s Disease Center and Movement Disorders Clinic, Baylor College of Medicine in Houston, Texas. Dr. Jankovic, a leader in the field of neurotoxin research, led the first studies of BOTOX(R) for the treatment of cervical dystonia and blepharospasm in the 1980s.
“Now it is decades later, and we have a wealth of clinical data on BOTOX(R), as well as expertise in its administration and a thorough scientific understanding of the product, and we know that optimal results with BOTOX(R) depend on several critical factors,” explained Dr. Jankovic. “Unlike oral drugs, there are many technical aspects involved in administering BOTOX(R), including dosing, dilution and injection placement and technique. Therefore, the injecting physician should have extensive knowledge of these treatment factors, along with a thorough understanding of the disease and its symptoms to ensure the product can deliver a targeted and precise effect.” Dr. Jankovic emphasized the importance to patients, whether they are considering medical treatment with BOTOX(R) or aesthetic treatment with BOTOX(R) Cosmetic (Botulinum Toxin Type A), of seeking a well-trained physician with the qualifications necessary to evaluate and determine the best injection plan for each patient.
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