Efficacy and Safety Results From a Pivotal, Phase 3 Study of TrenibotulinumtoxinE for Treatment of Moderate-to-Severe Glabellar Lines in Toxin-Experienced and Toxin-Naive Adults

BACKGROUND: Glabellar lines (GLs) are commonly treated with botulinum toxins; however, individuals may be hesitant to undergo treatment because of uncertainty around outcomes. OBJECTIVES: This Phase 3, double-blind, placebo-controlled study evaluated the safety and efficacy of trenibotulinumtoxinE (trenibotE), a botulinum neurotoxin serotype E, in toxin-naive and toxin-experienced adults with moderate-to-severe GL. METHODS: Participants were randomized 3:1 to receive either trenibotE (700 U) or placebo. The rigorous, multicomponent, primary endpoint was achieving a Grade 0 or 1 (None or Mild), with ≥2-grade improvement on the Facial Wrinkle Scale (FWS) at maximum frown by investigator and participant assessments on Day 7. Additional endpoints included FWS improvement over time, patient-reported outcomes, and assessments in participants who had appearance-related psychological impacts. Safety was monitored throughout. RESULTS: At Day 7, trenibotE was associated with significantly higher responder rates (60.0%) compared with placebo (0.6%) (P < .0001). Improvements began at Hour 8 (P < .001, unadjusted), peaked at Day 7, and returned to moderate-to-severe GL severity by Day 21. Treatment satisfaction was higher following trenibotE at Hour 8 (33.0% vs 13.8%; P < .0001, unadjusted), Hour 24 (59.2% vs 17.3%; P < .0001), and Day 7 (77.6% vs 5.1%). Higher satisfaction with natural-looking results following trenibotE treatment was first observed at Hour 8 (P < .0001, unadjusted) and peaked at Day 7 (78.5% vs 9.0% placebo; P < .0001). Most adverse events were mild, nonserious, and unrelated to study treatment. CONCLUSIONS: TrenibotE significantly improved GL severity with rapid results and short duration of effect. Participants reported high satisfaction with treatment and natural-looking results. The overall benefit-risk profile was favorable.