JAN 13, 2023

Developing the First and Only Peptide-Formulated Neuromodulator for Wrinkles

WRITTEN BY: Greta Anne

In a wrinkle-reduction market run by AbbVie’s Botox™ (active ingredient onabotulinumtoxinA), Revance was just approved to distribute DAXXIFY™ (DAXI), a drug that reduces the appearance of facial wrinkles. DAXXIFY™ received FDA approval back in September of 2022 after Phase 3 studies from the SAKURA clinical trial

The active ingredient in DAXI is DaxibotulinumtoxinA-lanm, and DAXI is the only neuromodulator drug that is stabilized with Peptide Exchange Technology, which means that it is highly positively charged. As we know, opposites attract, so this peptide technology allows DAXI to bind to the negatively charged core neurotoxin. It is also free of any human serum proteins and animal-based components, which is a major plus point for patients who wish to have products manufactured without the use of animal products. Abbvie’s Botox™ contains human albumin, which may be a hindrance for some patients to use it. 

 DAXI has a longer duration of action and response from patients than other onabotulinumtoxinA products marketed. DAXI has consistently showen high and consistent levels of efficacy, with the median duration of reducing wrinkles being 24 weeks. According to a study testing the efficacy of onabotulinumtoxinA, the active ingredient in Botox™, the median duration of complete efficacy is 56 days. To compare, DAXI’s median duration of efficacy is 168 days. The side effect profile between the two drugs is fairly similar, with no serious adverse events reported with either drug. 

Please see the video below describing the differences between DAXI and Botox™.

Ever since their FDA approval, Revance has slowly been testing out DAXI in various institutions through their “PrevU program,” where practices that attended on-site and virtual training sessions were able to practice patient injection days in their respective practices. This allows Revance to collect additional clinical data and real-world insight. DAXXIFY™ is expected to have its full-scale commercial launch in early 2023, and it will be exciting to see the future of DAXXIFY™ in skin concerns and various other indications. 

 

References

 Fabi SG, Cohen JL, Green LJ, et al. DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines: Efficacy Results From SAKURA 3, a Large, Open-Label, Phase 3 Safety Study. Dermatol Surg. 2021;47(1):48-54. doi:10.1097/DSS.0000000000002531

Nestor MS, Ablon GR. Duration of action of abobotulinumtoxina and onabotulinumtoxina: a randomized, double-blind study using a contralateral frontalis model. J Clin Aesthet Dermatol. 2011;4(9):43-49.

https://www.nytimes.com/2022/09/08/health/wrinkle-drug-botox-daxxify-fda.html

https://www.businesswire.com/news/home/20230109005255/en/Revance-Provides-an-Update-on-DAXXIFY®-Commercial-Launch-and-Preliminary-Fourth-Quarter-and-Full-Year-2022-Financial-Results

https://investors.revance.com/news-releases/news-release-details/revance-announces-fda-approval-daxxifytm-daxibotulinumtoxina