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

Abstract

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DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines: Efficacy Results From SAKURA 3, a Large, Open-Label, Phase 3 Safety Study

“…The safety outcomes from this trial based on the safety population are detailed in the companion article in this issue. 5 In brief, 1,043 (38.8%) subjects reported an AE, of which 29 subjects (1.1%) had a serious AE (all assessed as unrelated to treatment). One death occurred (homicide), and the 5 AEs leading to study discontinuation were basal cell carcinoma, bile duct cancer, “brow spocking,” fractured humerus, and optic neuritis; only the unnatural lateral brow elevation was considered to be related to treatment.…”

“…As described in the companion article on the safety outcomes from SAKURA 3, 5 this was a Phase 3, open-label, multicenter trial that evaluated single and repeat treatments of DAXI 40U, with post-treatment follow-up of up to 84 weeks ( ClinicalTrials.gov identifier NCT03004248). Specific targets for the number of subjects exposed to single versus repeat treatments were outlined in the protocol; therefore, a subset of enrolled subjects received more than 1 treatment.…”

“…Each DAXI vial was reconstituted with unpreserved saline, and all subjects received DAXI 40U (0.5 mL) in total: one injection in the procerus muscle and injections into both the medial and lateral corrugator muscles, bilaterally. 5 Subjects who received repeat treatments could be retreated between Week 12 and Week 36 after their first and second treatments if their IGA-FWS and PFWS scores had returned to baseline and other eligibility criteria were met. Subjects were followed for up to 36 weeks after each treatment, except for their final treatment, where follow-up ended at Week 12 to characterize safety outcomes after the third treatment.…”

“…The primary objective of this study was to evaluate safety, as reported in the companion article. 5 Efficacy was also evaluated using investigator and subject assessments of glabellar line severity at maximum frown and at rest (after maximum frown).…”

“…The efficacy analysis was designed to understand the efficacy and durability of the response in a much larger population than the pivotal trials and with repeat treatments. The safety results are reported in the companion article, 5 and here, the authors report on the efficacy of DAXI with up to 3 repeat treatments.…”