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Dr. Eppley Discusses New Botulinums in Development

Botox is a now a household name and one of the most popular and commonly performed cosmetic procedures in the world. Botox represents one form of botulinum A toxin of which there are at least eight forms. Currently, there are three additional forms of botulinum under some level of clinical development. The ones we are likely to hear about in the next year or so is Reloxin and PurTox. Besides the name, these different botulinum toxins are differentiated by how quickly they start to work, how long they will work, and how far from the injection site the drug will diffuse.
Reloxin, which is the name used in current U.S. clinical trials, is known as Dysport in Europe and other countries. Like Botox, Reloxin is a type A botulinum which lasts twice as long after mixing and has a different unit dosage. My understanding from readings at present is that the dose comparison is 3:1. (300 unit vial compared to 100 unit vial for Botox) Because Reloxin has a slightly different molecular structure than Botox, it diffuses out further from the injection site than Botox which may mean it can treat a larger area. (potentially needing less units than Botox to treat the same area and keeping a smoother look as it wears off) As of this writing, the Reloxin application to the FDA has been denied to being judged as having incomplete documentation. This certainly means that Reloxin will not likely be available in the U.S until 2009.
PurTox is not as far along in clinical development as Reloxin and is invery early clinical trials. I do not expect to hear much about this botulinum analogue until 2009/2010.
Dr Barry Eppley
http://www.eppleyplasticsurgery.com
http://www.ologyspa.com
Clarian North Medical Center, Carmel, Indiana
Clarian West Medical Center, Avon, Indiana
Indianapolis

Dr Barry Eppley, board-certified plastic surgeon, discusses recent issues about the safety of BOTOX cosmetic

The popularity of BOTOX® for the use in cosmetic facial wrinkle treatment, known as BOTOX® cosmetic, is due to its simplicity and tremendous effectiveness. It has become so familiar by popular culture and media communications that its name is often used as both a noun and a verb. (which is both disturbing and discouraged by the manufacturer) In my readings of recent publicity about outcomes with its use in children with neuromuscular disorders, I do not feel that the media has accurately portrayed many of the relevant safety issues about BOTOX® and how that relates to its use in the cosmetic patient. To allay potential patient concerns, it is useful to review some of the well-established information about this drug to clear up any confusion created by these media reports.

BOTOX® cosmetic and Botulinum Toxin Type A is manufactured by only one proprietary provider, Allergan out of Irvine, California. It has been 18 years since it was initially approved for the treatment of blepharospasm (excessive eyelid twitching) and 6 years since its approval for the cosmetic treatment of the vertical lines between the brows. While accurate numbers are impossible to know, tens of millions of cosmetic patients have been treated around the world with the manufacturer reporting more than 13 million doses given in the United States alone since 2002. According to the American Society of Plastic Surgery, BOTOX® cosmetic is the most commonly performed cosmetic procedure performed in the United States with over 3 million doses administered in 2006. These large patient numbers, combined with thousands of patients enrolled in various studies and over 3,000 published medical articles on the subject, provide a wealth of safety information. Despite the large amount of doses administered, significant adverse reactions to the use of BOTOX® cosmetic is extremely rare. I personally have never experienced any complications with its use, except for a few minor short-lived headaches after an injection session, since I have been treating patients with it. In addition, to date there has never been a single reported death associated with its use.

These cosmetic experiences must be contrasted with the media reports where its use was in the treatment of limb spasticity, which is not an FDA-approved application. In these neuromuscular uses, substantially larger doses (up to 100 times) are given compared to cosmetic doses and are injected in patients who are often ill and weakened from their disease. There simply is not a correlation between these two patient populations. The FDA clearly recognizes these differences and has issued no cessation of its uses to any health care provider at the present time for any of its approved indications. While no drug is ever completely without some complications, and all drugs will experience some complications if given in a high enough amount, the low doses used in the cosmetic patient are completely safe.

The accurate portrayal of the safety data on BOTOX® cosmetic should provide great comfort to those patients who regularly receive aesthetic treatments or to those considering it in the near future.
Dr Barry Eppley
http://eppleyplasticsurgery.com
http://ologyspa.com
Clarian North Medical Center, Carmel, Indiana
Clarian West Medical Center, Avon, Indiana
Indianapolis

Botox – How Does It Work?

Botox, the miracle drug of the cosmetic world, is so popular for one reason…..it simply works and it works well. While its effects are not permanent, usually lasting around four months or so, it is so effective at what it does that it is a near billion dollar drug in sales for its manufacturer, Allergan. (http://www.botoxcosmetic.com/)

Botox, or rather its generic name botulinum toxin from which it is derived, can cause botulism, a form of poisoning. Because botulinum bacteria produce neurotoxins, the disease brings forth images of paralysis and possible death. When I was a child, the most likely way to get botulism was from improperly canned food. Botulism bacteria in nature are encased and protected in spores. If canned food which contained any of these spores was eaten without cooking, botulism may be contracted. Proper heating of canned food kills the spores.

Botulinum bacteria produce a variety of neurotoxins, classified alphabetically from A to F. Botox is derived from toxin strain A. These neurotoxins attached themselves to the nerve endings right before they go into the muscle. Like an electric signal, the nerve endings activate the muscle by releasing a chemical neurotransmitter, acetycholine, which triggers muscle contractions. Botox works specifically by blocking release of acetylcholine from the nerve endings, essentially pulling the plug and removing the signal for the muscle to move. Historically, death from botulism poisoning was because it affected the respiratory muscles, allowing the affected patient to die from chemically-induced inability to breathe. On a much smaller scale if you paralyze a small muscle in the face, fro example, you decrease movement and hence the amount of wrinkling seen. Therein lies the difference between cosmetic Botox and deadly botulism.

Why are cosmetic Botox injections, then, not dangerous and don’t run the same risk as botulinum poisoning? Because the amount of toxin is incredibly small, diluted, and injected into a specific muscle rather than floating loose in the body. The use of Botox to treat human medical problems is not new. Since 1989, Botox has been used to treat painful muscle spasms in certain neurologic disorders and even the muscles around the eyes to treat persistent eyelid spasms. (blepharospasm) Botox was used ‘off-label’ for cosmetic facial wrinkling for years and, only in 2002, was it formally approved for these indications by the U.S. Food and Drug Administration (FDA). While it was only specifically studied for the treatment of glabellar (between the eyebrow) frowning, it can be used anywhere on the face where one wants to decrease the amount of muscle movement. The most comon area other than the glabellar region is the crow’s feet area. (wrinkling around the outside of the eyes)

Why are the effects of Botox only temporary? Obviously because the drug wears off, but it is not quite so simple at the microscopic level. The muscle movement recovers the blocked nerve endings sprout new growths called axons that bypass those nerve endings that are blocked. Like a potato in a dark closet, the nerve grows new ’sprouts’ which cross over and reattach to the muscle…..and it begins working again…after four months or so.

Botox is now widely used for many different medical problems, most of which are due to undesired muscle activity. (e.g., migraine headaches, rectal fissures) However, Botox also appears to be effective for many problems in which nerve blockage is desired but not necessarily to a muscle. It has been a miracle cure for the problem of hyperhidrosis, excess sweating of the armpits, hands and feet. When used for these problems, the effect of Botox lasts much longer (up to a year) although it is not completely understood as to why. (http://www.botoxseveresweating.com/) Anewer application for Botox, although investigational at this point, is in the treatment of hypertrophic and keloid scars. Again it is not injected into the muscle but into the newly forming scar. In some cases, this has been shown to be helpful. More work is needed however before it can be claimed that it is universally effective.

Dr Barry Eppley
http://www.eppleyplasticsurgery.com/
http://www.indianapolisbotoxdoctor.com/
http://www.ologyspa.com/
http://www.exploreplasticsurgery.com/
Clarian North Medical Center, Carmel, Indiana
Clarian West Medical Center, Avon, Indiana
Indianapolis