The FDA recently approved a new botulinum toxin A (BoTX-A) called Daxxify™ which will compete with Botox Cosmetic®, Dysport®, Xeomin®, and Jeuveau®.[1] I was one of the researchers on this FDA trial, so I am limited on what I am allowed to say, but I found Daxxify to work similarly to other BoTX-A on the market as far as how the research subjects looked, felt, and the side effects they experienced. The main difference in this new toxin to treat glabellar lines is that it lasted longer in the trials as compared to the other brands of BoTX-A. In fact, the median duration was about 6 months. (This does not mean that it is guaranteed to lasts 6 months in everyone.!) A few subjects showed effects up to 9 months.
What did the Daxxify studies show?
Less diffusion
In preclinical studies, Daxxify was shown to have less diffusion than Botox Cosmetic®. These data demonstrate that the limited diffusion may permit safe administration of higher and more efficacious doses.[2]
Responder rates
Pooled results from two Phase III pivotal studies with 609 adults to treat moderate to severe glabellar lines showed a responder rate of 72.6% at 16 weeks and 32.3% at 24 weeks in the DAXI group, respectively, versus 4.4% and 2.0% in the placebo group, respectively. Of the DAXI subjects, 98% had improvement of glabellar lines at maximum frown at four weeks versus 3.1% of placebo subjects. Furthermore, the median time to return to baseline glabellar line status was 27.1 weeks with DAXI. Treatment-related adverse events were reported in <20% of subjects and were predominantly mild. There were no new or unexpected safety findings observed and no subjects developed neutralizing antibodies to DAXI.[3]
Pivotal trial results that led to FDA approval
74% of subjects achieved a > two-grade improvement in glabellar lines at week 4 per both investigator and patient assessment
88% achieved > two-grade improvement at week 4 per investigator assessment
98% of subjects achieved none or mild wrinkle severity at week 4 per investigator assessment
6-month median duration
Some patients maintained treatment results at 9 months
Results seen as early as one day after treatment, typically seen within two days
What is Daxxify?
DAXXIFY (Revance Therapeutics Inc., Newark, CA) is a new type of BoTX-A product consisting of a purified 150 kDa molecule without any accessory proteins. It contains a proprietary stabilizing peptide called RTP004 in a lyophilized powder. The peptide is constructed on a backbone of consecutive lysines, which carry a positive charge, resulting in the peptide binding strongly to the BTX-A molecule through electrostatic bonds.[4]
What other research investigators have to say about Daxxify™[5]:
Jeffrey Dover, MD, co-director of SkinCare Physicians of Chestnut Hill, commented, “As a SAKURA investigator, I’m pleased to see DAXXIFY™ now approved as the first and only peptide-formulated, long-acting neuromodulator in the market. Compelling data from the largest Phase 3 clinical program ever conducted for glabellar lines demonstrated that DAXXIFY™ was well tolerated and achieved clinically significant improvement with long-lasting results and high patient satisfaction. Notably, DAXXIFY™ was able to demonstrate a long duration of effect while only utilizing 0.18 ng of core active ingredient in the 40-unit labeled indication for glabellar lines. With today’s approval, I look forward to helping patients, who have been accustomed to a 3 to 4-month duration profile with conventional neuromodulators, achieve year-long results with as few as two treatments per year.[6], [7], [8],[9]”
Daxxify is a welcome addition to our botulinum toxin arsenal against skin aging!
[1] Purpera, P. Botulinum Toxins in Baumann L. Baumann’s Cosmetic dermatology (McGraw Hill 2022)
[2] Stone HF, Zhu Z, Thach TQ, Ruegg CL. Characterization of diffusion and duration of action of a new botulinum toxin type A formulation. Toxicon. 2011;58(2):159-67.
[3] Kaufman-Janette JA, Solish N, Liu Y, Rubio RG, Gallagher CJ. Pooled results from 2 phase 3 pivotal studies of daxibotulinumtoxinA for the treatment of glabellar lines. Toxicon. 2018;156:S59.
[4] Glogau RG, Waugh JM. Preclinical transcutaneous flux experiments using a macromolecule transport system (MTS) peptide for delivery of botulinum toxin type A. Poster presented at the 66th annual meeting of the American Academy of Dermatology, San Antonio, TX, 2008.
[5] https://investors.revance.com/news-releases/news-release-details/revance-announces-fda-approval-daxxifytm-daxibotulinumtoxina
[6]Fabi, S. G., Cohen, J. L., Green, L. J., Dhawan, S., Kontis, T. C., Baumann, L., … & Rubio, R. G. (2021). DaxibotulinumtoxinA for injection for the treatment of glabellar lines: efficacy results from SAKURA 3, a large, open-label, phase 3 safety study. Dermatologic Surgery, 47(1), 48.
[7] Carruthers, J. D., Fagien, S., Joseph, J. H., Humphrey, S. D., Biesman, B. S., Gallagher, C. J., … & SAKURA, T. (2020). DaxibotulinumtoxinA for injection for the treatment of glabellar lines: results from each of two multicenter, randomized, double-blind, placebo-controlled, phase 3 studies (SAKURA 1 and SAKURA 2). Plastic and reconstructive surgery, 145(1), 45.
[8] Bertucci V, Solish N, et al. DaxibotulinumtoxinA for Injection has a prolonged duration of response in the treatment of glabellar lines: pooled data from two multicenter, randomized, double-blind, placebo-controlled, phase 3 studies (SAKURA 1 and SAKURA 2). J Am Acad Dermatol. 2020;82(4):838-845.
[9] Green, J. B., Mariwalla, K., Coleman, K., Ablon, G., Weinkle, S. H., Gallagher, C. J., … & Rubio, R. G. (2021). A large, open-label, phase 3 safety study of DaxibotulinumtoxinA for injection in glabellar lines: a focus on safety from the SAKURA 3 study. Dermatologic Surgery, 47(1), 42.