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Re: DewDiligence post# 244872

Wednesday, 12/28/2022 3:44:27 PM

Wednesday, December 28, 2022 3:44:27 PM

Post# of 257426
Not sure if this is significant, but the patient website, https://daxxify.com, uses language that is a bit less precise than what I believe is the healthcare provider site, https://daxxify.revanceaesthetics.com/

DAXXIFY™ lasts on average 6 months and up to 9 months for some.*
*At least 50% of patients in clinical studies had no or minor frown lines 6 months after treatment. Between 3% and 5% of patients in clinical studies had no or minor frown lines 9 months after treatment. In other safety studies, between 5% and 17% of patients still had noticeable improvement 9 months later.



v.

The first and only peptide-powered, FDA-approved frown line treatment with a median duration of 6 months and up to 9 months for some patients.1-9*
*At least 50% of patients in SAKURA 1 and SAKURA 2 had none or mild frown lines for 24 weeks (6 months) and 23.9 weeks (6 months) or longer, respectively, per both investigator’s and patient’s assessments. 5% of patients in SAKURA 1 and 3% of patients in SAKURA 2 had none or mild frown lines at 9 months per investigator’s assessment. In SAKURA 1, SAKURA 2, and SAKURA 3 OLS Treatments 1 and 2, 7.5%, 5.4%, 17.4%, and 11.6% of patients, respectively, had not returned to baseline severity at 9 months per both investigator’s and patient’s assessments. 2,7,8

...

2. 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.


7. Carruthers JD, Fagien S, Joseph JH, et al. 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). Plast Reconstr Surg. 2020;145(1):45-58.

8. Data on File. Protocols 1620301-303. Post Hoc Analysis. Newark, CA: Revance Therapeutics, Inc, 2021.

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