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treatment & management

Drug Profiles:
Botox® (botulinum toxin)

CAUTION:
Federal law prohibits dispensing without prescription.

What is Botox ®

According to a recent University Of California, San Francisco study delivered in a presentation at the American Society of Dermatologic Surgery meeting (held November 2-5, 2000), Richard Glogau, MD, UCSF professor of dermatology, reported that 75 percent of patients in his case study experienced four to six months of Migraine relief following injections of Botox® (botulinum toxin A derived from bacteria) to muscles of the face and head. Glogau's small study of 24 patients adds weight to previous reports that botulinum toxin A can relieve Migraines.

Since 1992, Botox®, the same bacteria that causes deadly food poisoning, has been used in purified and diluted form to temporarily paralyze the muscles that bring the eye brows together, thereby eliminating wrinkles in this region. practice injected with botulinum toxin A in the upper third of the face for treatment of cosmetic frown lines (who coincidentally suffered from Migraines) have reported the added benefit of Migraine relief.

   

How Botox® Is Currently Being Used To Treat Migraine Disease

Following this serendipitous discovery by the University Of California, San Francisco professor Glogau and other researchers began to evaluate injection points and dosages that could alleviate Migraines. Glogau's results indicate that botulinum toxin A injected into the muscles of the brow, eyes, forehead, side of the head and back of the head near the neck (a point that earlier investigators have neglected) induce sometimes immediate Migraine relief and provide benefit for up to six months, he said. Botox® dosage in his case studies averaged 80 units per patient.

There are no published, randomized, double-blind trials that show the safety and efficacy of Botox® for treatment of Migraines, Glogau said. In fact, most of the data consists of case reports and meeting abstracts. Two previous studies were presented at the 1999 meeting of the American Association for the Study of Headache (Now know as the American Headache Society). In the first study, reported by researchers at the Michigan Head Pain and Neurological Institute in Ann Arbor and Michigan State University, a one-time dose of 25 units of botulinum toxin A injected into the muscles of the brow, forehead and side of the head, reduced the frequency of Migraines, the severity of pain, vomiting, and the use of pain medications for up to three months. A 75-unit treatment yielded Migraine relief, but also side effects like eyelid drooping. In another study, reported by researchers at the University of California, Los Angeles, 51 percent of 96 patients reported complete improvement of their Migraine pain.

Cost & Use of this Preventive Migraine Treatment

One limitation for botulinum toxin's (Botox®) use in treating Migraines is cost. Unlike other treatments for Migraines, such as the prescription drug Imitrex® and nasal sprays (and other triptans or ergotomine drugs), Botox® injections are not covered by insurance and cost about $350 for each targeted area, (and will likely be used in multiple areas) so it appears expensive. But the cost has to be looked at divided by the 4 to 6 months that this preventive works between doses as compared to other preventive drug costs. In addition, it is important to note that prescription drugs like Imitrex® and nasal sprays are abortive treatments and not designed to replace nor use like Botox®, which is to be used as a preventative or prophylactic Migraine treatment. Possibly with some Migraineurs, they may find this botulinum toxin's use can prevent all of their attacks for up to four or more months. But for others, like many Migraine sufferers using prophylactic Migraine treatments, may discover it greatly lowers the frequency and severity of an intractable Migraineur’s attacks. These individuals can then turn to abortive the prescription drugs Imitrex® (or other equally good triptans) and nasal sprays or use rescue drugs like butorphanol tartrate (Stadol®) to deal with the breakthrough attacks. So discuss this with your physician as part of an overall Migraine treatment plan including trying the Botox® for preventive treatment, as well as a good abortive treatment plan, trigger management, and pain management plan to deal with your Migraines.

History of Botulinum Toxin Type A

Clostridium botulinum produces 7 distinct toxins, types A through G. Botulinum toxin type A is the most studied of the 7 stereotypes produced by the anaerobic bacterium Clostridium botulinum. Minute quantities of botulinum toxin type A offer significant potential in treating a wide variety of disorders associated with muscle overactivity.

Work with botulinum toxin type A as a therapeutic agent to treat human disease began in the late 1960s through the collaboration of Alan B. Scott, MD, of the Smith-Kettlewell Eye Research Foundation and Edward J. Schantz, PhD, director of food microbiology and toxicology at the University of Wisconsin. This is when botulinum toxin type A was first considered not as an agent of human sickness and disease but as a powerful therapeutic agent to treat symptoms of neurological disorders.

In 1989, the rights to a form of botulinum toxin type A, currently commercialized under the trade name BOTOX®, were acquired by Allergan, Inc. In December of that same year, BOTOX® was approved for use in strabismus and blepharospasm associated with dystonia in patients 12 years of age and above. Through the collaboration of Drs. Scott and Schantz, and the pioneering efforts of Allergan, BOTOX® was added to the armamentarium of drugs used to treat these conditions.

Clinical Development

BOTOX® is currently in various stages of clinical development for a number of neuromuscular treatments. If successful, these treatments could offer new tools with potential to improve various patient conditions.

Allergan's BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex is used in the treatment of certain neuromuscular disorders characterized by involuntary muscle contractions or spasms. Allergan markets BOTOX® in the United States and in 61 other countries. The approved indications for BOTOX® in the United States are for the treatment of blepharospasm (the uncontrollable contraction of the eyelid muscles that can force the eye closed and result in functional blindness) and strabismus (misalignment of the eyes) in people 12 years of age and over. For approved uses outside of the United States, please contact our global offices.

Manufacture and Storage

BOTOX® is supplied sterile in glass vials, each containing 100 units. BOTOX® must be diluted with sterile, nonpreserved saline immediately prior to its injection.

Summary

The clinical use of BOTOX® represents one of the most dramatic role reversals in modern medicine: a biologic toxin transformed into a therapeutic agent.

For More Detailed Information

For more detailed information regarding BOTOX® Allergan’s (the manufacture) webpage at:

http://www.botox.com/noflash_index.html.

We would like to credit the University Of California, San Francisco as an original source for part of this section. You may also wish to visit the following link for more background on the botulinum toxin Migraine studies.

http://www.sciencedaily.com/releases/2000/11/001120074720.htm