Revance RT002—A new botulinum toxin: Separating fact from hype.
You may have heard about a new botulinum toxin A product called Revance RT002. The drug has yet to achieve FDA approval but all indications are that this will occur allowing the Revance botulinum toxin product into what is already a crowded neurotoxin market. It would compete with products like Allergan’s BOTOX, Merz’s Xeomin, or Galderma’s Dysport. Is there room in the market for a fourth “me too” product? The unique value proposition being floated in premarketing hype is that this botulinum toxin A product has a longer lasting clinical effect. If this were true, it would be a market advantage for this new botulinum toxin product. The history of the cosmetic market being what it is, a skeptical eye is warranted in evaluating these claims.
Revance Therapeutics Inc. is a publicly traded pharmaceutical company based in Newark, California. First, it’s important to understand that their new product is still under premarket testing, meaning that it is not yet \ FDA approved. That means you can’t go down the street and request this product yet.
A phase 2 study of RT002, also known as DaxibotulinumtoxinA has been completed. This work was performed by Jean Carruthers and colleagues in Canada. Jean and her husband Allistar Carruthers invented the cosmetic use of botulinum toxin by being the first to formally use the product as a cosmetic treatment on a series of individuals. A phase 2 study evaluates the performance of a claimed treatment for its effectiveness. The so-called BELMONT study of DaxibotulinumtoxinA compared various doses of RT002 with cosmetic BOTOX for glabellar lines. Prior studies of DaxibotulinumtoxinA have established that it is equipotent to Onobotulinumtoxin A (BOTOX). That means that to compare apples to apples, one would compare say the effect of 20 units of BOTOX to 20 units of RT002. That is not what was done in the studies. Instead investigators compared RT002 doses of 20, 40, and 60 units to BOTOX 20 units. Not surprisingly, the higher doses of RT002 last a bit longer than a 20-unit dose of BOTOX. We see that clinically with BOTOX that larger doses have a longer lasting clinical effect than smaller doses. That does not create real confidence in the pre-marketing claims that RT002 lasts longer than BOTOX. Marketing materials put out by Revance also suggest that the stabilizing proteins associated with RT002 limit its diffusion once injected. Again, if this were true, it might be a meaningful distinction. However, a certain degree of skepticism is warranted. This may or may not prove to be clinically relevant difference.
It is not clear when Revance’s RT002 (DaxibotulinumtoxinA) will take its place in the market as another botulinum toxin product in a crowded market place. What is clear is that its maker has been consistently trying to make a case for the relevance of its new product. However, the market will rapidly sort out the maker’s claims. The market is sophisticated enough that marketing hype alone is not likely to convey a marketing advantage. As the market becomes increasing more crowded, the likelihood of a price war among these products becomes increasingly more likely. So far, the manufacturers have resisted market pressure to adjust their pricing.
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