While Botox has long been in a battle with fighting wrinkles, it will soon be facing a new challenge….competition. Since Botox’s formal Food and Drug Administration (FDA) approval for its use in cosmetic facial applications (it had been used off-label for more than a decade before that), it has been unrivaled racking up sales close to $1 billion annually.

Within the next few months (April 13, 2009), the FDA is expected to approve a new injectable cosmetic wrinkle treatment known under the tradename Reloxin. Made from the same neurotoxin as Botox (botulinum toxin of type A), Reloxin is touted to act more quickly and perhaps somewhat longer than Botox. The U.S. distribution rights of Reloxin are owned by the Medicis company, who currently sells the popular injectable filler Restylane.

Reloxin is currently used around the world under different names such as Dysport and Azzalure. It is a neuromuscular blocking toxin and was initially developed for the treatment of motor disorders and various forms of muscular spasticity, including cervical dystonia, spasticity of the lower limbs in children with cerebral palsy, blepharospasm (involuntary eye closure) and hemifacial spasm. It was later developed for the treatment of a wide variety of neuromuscular disorders and aesthetic facial treatments. Since its use has been expanded to aesthetic medicine, it is approved in 23 countries: Argentina, Australia, Belarus, Brazil, Columbia, Ecuador, Egypt, El Salvador, Germany, Honduras, Israel, Kazakhstan, Mexico, Moldova, New Zealand, Philippines, Slovak Republic, South Korea, Ukraine, Uruguay, Venezuela, Vietnam, and Russia.

While the differences between Botox and Reloxin will no doubt be heavily debated in major marketing battles yet to come, the bottom line to patients is that we may see lower prices for these treatments. At worst, the prices will be the same, but I doubt it. The competition and incentives to get physicians to use them will unquestionably drive per treatment prices down. In most every other country in the world where both Botox and Dysport/Reloxin co-exist, the market is fairly evenly split between the two. I would expect to see the same phenomenon here in the U.S. within the next few years. 

The difference between Reloxin and Botox, according to clinical trial reports from the manufacturer is that Reloxin will act in one to two days instead of the three to five days that is needed for Botox. I am not sure that is such a significant advantage but early onset action is a value added benefit. The far more important benefit would be a longer duration of action. It is suggested that Reloxin may last as long as five or six months, compared to three or four months for Botox. If consistently effective and reproducible for the majority of patients, this would be a significant difference that would have widespread patient appeal.

Is Reloxin hype or hope? We’ll know by this time next year.

Dr. Barry Eppley

http://www.eppleyplasticsurgery.com

http://www.ologyspa.com

Clarian North Medical Center, Carmel, Indiana

Clarian West Medical Center, Avon, Indiana

Indianapolis

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 these botulinum analogues until 2009 or 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