Rapid Results With TrenibotulinumtoxinE for the Treatment of Glabellar Lines in Toxin-Naive Adults: Safety, Efficacy, and Satisfaction Findings From a Pivotal Phase 3 Study

BACKGROUND: All currently approved botulinum toxins for treatment of facial lines, such as glabellar lines (GL), are of serotype A (BoNT/A). OBJECTIVES: This 12-week, phase 3, double-blind (DB), placebo-controlled study evaluated the safety and efficacy for trenibotulinumtoxinE (trenibotE), a first-in-class botulinum toxin serotype E, in toxin-naïve adults with moderate to-severe GL. METHODS: Participants with no prior toxin treatment were randomized 3:1 to trenibotE (700 U) or placebo. The rigorous, multi-component primary endpoint was achieving grade 0 or 1 (None or Mild) with ≥ 2-grade improvement on the Facial Wrinkle Scale (FWS) at maximum frown at day 7, assessed by both investigator and participant. Additional endpoints included FWS improvements over time and patient-reported outcomes. Safety was monitored. RESULTS: Of 309 participants (79.3% female, 83.2% White, mean age of 43.1 years), the effects of trenibotE were observed at hour 8, peaked at day 7, and returned to moderate or severe severity by day 21. At day 7, 65.7% who received trenibotE achieved the primary endpoint vs 1.2% placebo (P < .0001). Treatment satisfaction at hour 24 and day 7 was higher in the trenibotE group (69.3% and 84.9%, respectively) than placebo (13.7% and 9.8%, respectively). At day 7, 84.7% of participants reported satisfaction with natural-looking results. Most TEAEs were mild, non-serious, and unrelated to treatment. There were no serious, treatment-related TEAEs and no cases consistent with distant spread of toxin. CONCLUSIONS: TrenibotE was well tolerated and improved GL severity in toxin-naïve participants, with rapid results and short duration of effect. Participants were satisfied with overall treatment and their natural-looking results.