Ring in the New Year with a New Tox?

Written by Dr. Lisa Vuich, Renew Medispa

Ring in the New Year with a New Tox?

A 6 Month Wrinkle Relaxer is Closer than you Think!

Botulinum toxin injections have soared year to year ever since the Doctors Carruthers first began using their Botulinum Toxin for cosmetic indications back in the 1970s. According to the 2019 report of the American Society of Plastic Surgeons, over 7.7 million botulinumtoxinA injections are estimated to have occurred in 2019 in the USA alone. It routinely ranks #1 in the Top 5 Minimally Invasive Cosmetic Procedures list year after year.

Currently there are 4 botulinumtoxinA brands on the market which are FDA approved for cosmetic use- Botox (AbbieVie/Allergan), Dysport (Galderma), Xeomin (Merz) and Jeuveau (Evolus) -the latter of which has been marketed during this past year with the tagline “NewTox”. As the newest toxin/wrinkle relaxer launched in the cosmetic injectable market, Jeuveau was initially priced very competitively- and we were pleased to offer it at a reduced price, passing that savings on to our guests at Renew MediSpa. 

A few key points before I move on : 

• All of the botulinum toxins have the same active ingredient, but differences in the manufacturing process do lead to subtle differences in the patient’s experience- such as onset of action, potency and duration of effect.
• This is in part due to the fact that the “units” of one botulinum toxin brand are NOT interchangeable with the “units” of another brand. In practice we have what we consider to be “equivalent dosing” that we use if transitioning a patient from one brand to another. Put another way, a “100 unit” vial of Xeomin does NOT contain the same amount of active toxin as a “100 unit” vial of Jeaveau or a “100 unit” vial of Botox! And a “300 unit” vial of Dysport contains MORE active toxin than three “100 unit” vials of any of the other brands put together. Confusing, I know! 

Enter Revance Therapeutics: a biotechnology company focused on innovative aesthetic and therapeutic products, including its next-generation, wrinkle relaxer: (generic name) DaxibotulinumtoxinA. What trade name they market this under has yet to be revealed, but DaxibotulinumtoxinA is under final review with the U.S. Food and Drug Administration (FDA) for glabellar (frown) lines as well as other aesthetic and several medical indications (Migraine, Plantar Fasciitis, Cervical Dystonia and Adult Upper Limb Spacticity after Stroke or Brain Injury). DaxybotulinumtoxinA is a highly purified botulinum toxin which unlike some others does not contain any human (albumin) or animal based components, which may be additionally attractive to some consumers. The Doctors Carruthers, the original pioneers of the cosmetic uses of botulinum toxin, were even lead investigators in the Revance studies. 

Currently its final approval is delayed because the FDA needs to complete a final site visit, and the Revance Therapeutics site is located in California where Coronavirus is currently raging (thus no travel at this time for FDA agents to that region). The company is in the process of moving its headquarters from California to Tennessee, and their products will be manufactured in the USA. At a time when one brand (Jeuveau) is being squeezed out of the market so to speak by legal battles, it will be interesting to see what happens when the “6 month botox” hits the shelves! Some had questioned whether a wrinkle relaxer with longer duration of action would also have longer duration of potential side effects, but that was not borne out in the clinical studies. Side effect profile was not significantly different from that of other brands.

So, what does this all mean for the consumer/patient? Well, expect to see some market shift in pricing. While this new competitor prepares to launch, AbbVie Inc.’s Allergan and its Korean partner Medytox Inc. have been winning U.S. trade disputes in court, in which they seek to block imports of Evolus Inc.’s Jeuveau. This month the U.S. International Trade Commission upheld a judge’s previous finding that Evolus and Daewoong manufactured Jeuveau with a secret process stolen from AbbVie’s South Korean partner. A previously proposed 10-year ban on Jeuveau imports was reduced to 21 months, but the price per vial has nearly doubled for those of us in the industry and I remain skeptical about future availability of Jeuveau in the US. Some practices, including my own, will likely run out of current stock of Jeuveau and decline to order more, preferring instead to launch the DaxybotulinumtoxinA “6 month botox” as soon as it is available. 

For anyone who would like to understand more about toxin dosing, I invite you to visit our Specials page at www.renewmedispa.com. There is a link to a free webinar I developed, called “The Truth About Tox”, which explains botulinum toxin actions, dosing, etcetera. No doubt I will need to update that webinar in 2021 to include more information about DaxybotulinumtoxinA as it becomes available.