Resumen

Objectives: To establish the safety and impact on duration of effect of 40U of the injectable neuromodulator, prabotulinumtoxinA-xvfs, in providing temporary improvement in the appearance of moderate to severe glabellar lines in adult subjects, as measured at maximum frown on the 4-point Glabellar Line Scale (GLS: 0=none, 1=mild, 2=moderate, 3=severe). Introduction: There is an interest in exploring strategies to increase the duration of effect of botulinum toxins. Several injectable neuromodulator botulinum toxins type A have been approved for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugators and/or procerus muscle activity. PrabotulinumtoxinA-xvfs at a dose of 20U was approved for this use in 2019. More recently, the safety and the impact on duration of effect of increasing doses of these toxins have been the subject of additional post-approval investigations. Materials / method: Blinded analyses were performed in Sept 2022 on baseline data of the 154 adult patients with moderate to severe glabellar lines who were enrolled in a Phase II, multicenter, randomized, double-blind, active-controlled study in which patients were randomized 1:1:1 to a single treatment of either 20U onabotulinumtoxinA, or 20U or 40U prabotulinumtoxinA-xvfs. GLS and other outcomes were assessed on Days 3, 7, 30 and every 30 days thereafter up to 365 days or until the subject had returned to baseline. Interim analyses investigating safety, efficacy and duration will be performed in Jan 2023. Results: The 3 blinded treatment groups, Groups A, B and C, had mean ages of 46.8, 47.0 and 46.8 years, respectively. Most participants in each group were female: 94.1%, 94.0% and 94.3%, respectively. Most were white: 96.1%, 94.0% and 92.5%, respectively. Approximately one third were Hispanic or Latino: 39.2%, 32.0% and 28.3%, respectively. Importantly, the mean GLS scores at maximum frown at baseline were identical: 2.7±0.5 in each of the 3 groups. Conclusion: The demographic characteristics of the three treatment groups were well-balanced. For the first time, data will be presented on the safety, efficacy and duration of effect of 40U prabotulinumtoxinA-xvfs, which represents a doubled dose and hyper-concentrated formulation. This will be an interim analysis of an ongoing trial.