A Large, Open-Label, Phase 3 Safety Study of DaxibotulinumtoxinA for Injection in Glabellar Lines: A Focus on Safety From the SAKURA 3 Study

Jeremy B Green, Kavita Mariwalla, Kyle Coleman, Glynis Ablon, Susan H Weinkle, Conor J Gallagher, Domenico Vitarella, Roman G Rubio, Jeremy B Green, Kavita Mariwalla, Kyle Coleman, Glynis Ablon, Susan H Weinkle, Conor J Gallagher, Domenico Vitarella, Roman G Rubio

Abstract

Background: SAKURA 3 was a Phase 3, open-label, repeat-dose safety study of DaxibotulinumtoxinA for Injection (DAXI); a component of the largest Phase 3 clinical development program of an aesthetic neuromodulator in glabellar lines.

Objective: To evaluate the use of DAXI (40U) up to 3 treatments for moderate or severe glabellar lines.

Methods: Eligible subjects rolled over from the placebo-controlled trials (n = 477) or were de novo (n = 2,214) and received 1 to 3 treatments over a maximum of 84 weeks. Safety and efficacy were evaluated at least every 4 weeks up to Week 36 (Treatments 1 and 2) and Week 12 (Treatment 3). Select subjects could be retreated after Week 12 if glabellar lines returned to baseline.

Results: Safety results are reported for 2,691 subjects, of which 882 received a second treatment and 568 a third. Treatment-related adverse events (AEs) occurred in 17.8% of subjects, which were generally mild and resolved. No serious AEs were treatment-related. Eyelid ptosis occurred in 0.9% of treatments. Adverse events were consistent across treatments and no new safety signals were observed.

Conclusion: The safety of DAXI in this large open-label safety study confirms the findings from the pivotal Phase 3 trials, providing reassurance in its overall safety profile.

Trial registration: ClinicalTrials.gov NCT03004248.

Conflict of interest statement

J.B. Green, K. Mariwalla, K. Coleman, and G. Ablon have served as clinical trial investigators for Revance Therapeutics, Inc. S.H. Weinkle has served as a clinical trial investigator and consultant for Revance Therapeutics, Inc. D. Vitarella, C.J. Gallagher, and R.G. Rubio are employees of, and hold stock/stock options in Revance Therapeutics, Inc.

Copyright © 2020 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Society for Dermatologic Surgery, Inc.

Figures

Figure 1:
Figure 1:
Study design.

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Source: PubMed

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