The A, B, and CD of Botulinum Toxins

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Knowing the Facts about Alternative Treatment Options

Eric J Pappert, MD

Which of the following statements are true: Botulinum toxins cause food poisoning, or, botulinum toxins are a safe and effective treatment for people with cervical dystonia (CD)? It may come as a surprise to many, but people with CD have reason to know that both statements are actually true. Botulinum toxins are proteins produced by a germ or bacteria called Clostridium botulinum. 1 Once only thought of as the cause of food-poisoning or botulism, botulinum toxins in purified injectable form are now recognized as an important “first line” (initial) and long-term treatment for conditions such as CD, and they are the medicine most often used to treat CD today. 1,2

Just as there are different strains of naturally occurring botulinum bacteria, scientists have identified multiple distinct forms (types) of botulinum toxins. Medicines made from purified forms of two different types of botulinum toxin have been approved by the Food and Drug Administration (FDA) for use in treating CD. 2 Those products are available commercially as Myobloc® (Botulinum Toxin Type B) Injectable Solution and Botox® (Botulinum Toxin Type A). Although the Botox name may be familiar due to its prior use in treating other medical and cosmetic conditions, MYOBLOC was actually the first botulinum toxin to be approved in the United States for treating CD. 2

Determining the course of treatment for CD requires not only good communication between patient and doctor, but also accurate information about available treatment options. Patients with CD who might benefit from botulinum toxin therapy should talk with their physician to select one of the approved toxin treatments. Below are some facts for patients to keep in mind when preparing to discuss CD treatments and botulinum toxins with their doctor.

Fact: Both MYOBLOC and Botox are approved by the FDA as safe and effective for the same CD treatment uses: reducing abnormal neck position and pain associated with CD. 3 For both products, the FDA’s approval was based on clinical studies in which each product was compared to a placebo (injection with no drug). 2

Fact: Both MYOBLOC and Botox are used by physicians as the first toxin treatment for patients with CD. 3 MYOBLOC has been studied in patients previously treated with Botox as well as in patients who have never received a botulinum toxin treatment.

When choosing a botulinum toxin treatment for a patient with CD, a physician may consider whether or not the patient has been previously treated with a botulinum toxin and how well he or she responded to that treatment. 2,4

Fact: The botulinum toxins in MYOBLOC and Botox attach to different proteins on nerves, but they both can help to relax muscles. 2,5 While researchers continue to study Type A and Type B toxins, there is no current evidence that either MYOBLOC (Type B) or Botox (Type A) is safer or more effective than the other for treating CD. 3,6 Indeed, clinical studies that compared the performance of MYOBLOC and Botox in CD patients have shown that they offer similar treatment benefits. 3,6

Fact: Human studies comparing MYOBLOC to Botox showed the relief from pain and muscle symptoms appeared to last for about the same amount of time for both treatments. 3

Fact: Like all prescription medications, botulinum toxins have potential risks as well as potential benefits. Physicians always consider the balance between risk and benefit before choosing either MYOBLOC or Botox to treat a given patient with CD. 7,8 Likewise, patients should ask their doctor to explain their treatment options and to answer any questions they may have.

In cervical dystonia patients, the most frequently reported adverse events with botulinum toxin Type B (MYOBLOC) are dry mouth, dysphagia, dyspepsia, and injection site pain. 9 For patients treated with botulinum toxin Type A (Botox) for cervical dystonia, the most frequently reported adverse reactions were dysphagia, upper respiratory infection, neck pain, and headache. 10 For a more detailed explanation, refer to the full Prescribing Information for each product.

CONCLUSION

Researchers are continuing to evaluate existing CD treatment alternatives, and are working to develop new treatments for CD. In this decade, botulinum toxin therapy has made important contributions to the treatment of CD. The availability of two botulinum toxin products has provided additional flexibility in treatment choices. 4 As treatment options expand, patients must continue to learn more about those options. Effective doctor-patient communication, as well as access for patients to accurate information about potential treatment options remain among the most effective tools for managing the treatment of CD. 4

Myobloc® is a registered trademark of Solstice Neurosciences, Inc.
Botox® is a registered trademark of Allergan, Inc.

Solstice Neurosciences, Inc. Patients: about myobloc®. Available at: http://www.myobloc.com/pat_about/about.html. Accessed April 30, 2007
Factor SA, Molho ES, Evan S, Feustel PJ. Efficacy and safety of repeated doses of botulinum toxin type B in type A resistant and responsive cervical dystonia. Mov Disord. 2005;20:1152-1160.
Pappert E, Germanson T. Botulinum toxin type B vs type A in toxin-naïve patients with cervical dystonia: randomized, double-blind, non-inferiority trial. Mov Disord.
2007;3-15.
Dystonia Medical Research Foundation. Optimizing results. Available at: http://www.dystonia-foundation.org/pages/optimizing_results/127.php. Accessed
April 30, 2007.
Solstice Neurosciences, Inc. Patient information: therapeutic botulinum toxins.
Comella CL, Jankovic J, Shannon KM, et. al. Comparison of botulinum toxin serotypes A and B for the treatment of cervical dystonia. Neurology. 2005; 65: 1423-1426.
Solstice Neurosciences, Inc. Patients: treating cervical dystonia. Available at: http://www.myobloc.com/pat_about_cd/treat.html. Accessed April 30, 2007
Solstice Neurosciences, Inc. Healthcare professionals: about myobloc®. Available at: http://www.myobloc.com/hp_about/about.html. Accessed April 30, 2007.
Myobloc® full Prescribing Information. Solstice Neurosciences, Inc., South San Francisco, California, 2004
Botox® Prescribing Information, Allergan, Inc., Irvine, California, 2006

My mom and I wanted to thank you for hosting such a great symposium this year. This was our third year and we are looking forward to next years. E. Mathews