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    Neurotoxin pipeline advances, stay wary of counterfeits


    In the pipeline

    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.

    READ: Best practices for neurotxins

    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.


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