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

ABSTRACT:

Background

DaxibotulinumtoxinA for Injection (DAXI) is botulinum toxin Type A formulated with a novel peptide excipient. Two pivotal, single-treatment, placebo-controlled trials demonstrated efficacy and safety for moderate or severe glabellar lines.

Objective

To further evaluate DAXI in a large, open-label, repeat-treatment study.

Methods

Subjects (n = 2,691) were enrolled from the preceding pivotal trials or de novo and received 40U DAXI. Those who received repeat treatments could be retreated when they returned to baseline on the Investigator Global Assessment-Frown Wrinkle Severity (IGA-FWS) and Patient FWS (PFWS) scales at/after 12 weeks and up to 36 weeks after treatment.

Results

High (>96%) response rates (none or mild severity) on the IGA-FWS scale were

SUBMITTER: Fabi SG 

PROVIDER: S-EPMC7752211 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature