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As the neurotoxin market is set for expansion, so expands the market of counterfeit products. One expert reviews the innovative options coming up through the pipeline and cautions colleagues about the risks associated with counterfeits.
The neurotoxin armamentarium may be expanding in the not-to-distant future as several injectable toxins are now being evaluated in U.S. clinical trials. At the start of 2016, however, cosmetic and dermatologic surgeons can and should be satisfied using any of the three botulinum toxin products that have FDA approval, said Michael H. Gold, M.D., who provided a review of neurotoxins on the radar during the MauiDerm 2016 meeting. In addition, he cautioned about the risks associated with the use of counterfeit products.
Michael H. Gold, M.D“The bottom line for physicians in the United States is that we have three phenomenal neurotoxin products to choose from, and individual practitioners can decide which they want to use based on their personal experience with these products and their relationships with the different manufacturers,” he said. Dr. Gold is owner, Gold Skin Care Center, Tennessee Clinical Research Center, Nashville, Tenn.
“At the same time, there are many counterfeit toxins and they are readily available. Don’t be foolish and naïve in thinking that you can purchase these lower priced products outside of conventional sources and will simply be buying yourself a better deal. Realize these are fake materials that can cause serious problems for both patients and users,” he warned.
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In his update on what’s coming in neurotoxins, Dr. Gold first pointed out that the three neurotoxins that are available in the United States go by different tradenames in other parts of the world. In some international markets, Botox Cosmetic (onabotulinumtoxinA, Allergan) is known as Vistabel, Xeomin (incobotulinumtoxinA, Merz) goes by BoCouture, and Dysport (abobotulinumtoxinA, Galderma) is named Azzulare.
Injectable toxins in the investigational pipeline in the United States include ready-to-use products being developed by Galderma and Ipsen that have completed phase 2 studies. In addition, Alphaeon has acquired rights to a product from a South Korean company that is finishing phase 3 studies, and Chroma has entered into a marketing agreement to develop a neurotoxin originating from another South Korean company. Revance has a candidate product that is being developed as both a topical gel for treatment of lateral canthal lines and as an injectable. The topical formula is being evaluated in a phase 3 study and the injectable version will enter phase 3 testing later in 2016.
Dr. Gold said that while China is the source of most fake toxins, there is one legitimate neurotoxin from Chinese manufacturer Lanzhou Biological Products Institute that is approved by the Chinese equivalent of the U.S. FDA. Sold under different names in some South American countries, Russia, and Indonesia, the “ChinaTox” product is cheaper than onabotulinumtoxinA. In an open-label comparative study evaluating the two agents to treat focal spasm and dystonia, ChinaTox was less potent than onabotulinumtoxinA (ie., higher doses were required) and also associated with cases of skin rash.
The counterfeit toxins, like all other knock-offs, are packaged so that they look identical to the real thing. Results of a study evaluating the activity of the material in these look-alikes showed they either contained no toxin at all or had potency that significantly exceeded the labeled units.
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In his cautionary message, Dr. Gold reviewed cases involving physicians in the United States who were investigated by the FDA Office of Criminal Investigations for injecting these unapproved products. They were indicted for drug misbranding and mail fraud among other crimes. Upon conviction, the physicians were sentenced to prison terms of 12 months and longer as well as ordered to pay restitution and other fines in amounts of tens to hundreds of thousands of dollars.