Safety, Pharmacodynamic Response, and Treatment Satisfaction With OnabotulinumtoxinA 40 U, 60 U, and 80 U in Subjects With Moderate to Severe Dynamic Glabellar Lines

OnabotulinumtoxinA 20 U reduces glabellar line (GL) severity at maximum frown for ≈3-4 months. Small studies have suggested that >20 U doses may increase efficacy and duration of response for GLs. Evaluate safety, pharmacodynamic response, and treatment satisfaction with onabotulinumtoxinA doses ≥20 U for GLs. This 48-week, double-blind study compared 40, 60, and 80 U onabotulinumtoxinA vs 20 U and placebo in women with moderate or severe dynamic GLs on the Allergan Facial Wrinkle Scale (FWS). Percentage of subjects with investigator-assessed ≥1-grade FWS improvement from baseline at maximum frown (responders) at week 24; estimated median duration of response; proportion of mostly/very satisfied responders on the Facial Line Satisfaction Questionnaire (FLSQ) follow-up Items 1-5; and treatment-emergent adverse events (TEAEs) were evaluated. The modified intent-to-treat population (N=226) had a mean age of 48.0 years, with similar baseline GL severity between treatment groups. Week 24 responder rates were 0% for placebo and 16.0%, 32.0%, 30.6%, and 38.5% for onabotulinumtoxinA 20, 40, 60, and 80 U, with significant (P