注射用 DAXXIFYTM(DaxibotulinumtoxinA-Lanm),用于肌肉注射。

Skinmed Pub Date : 2024-09-17 eCollection Date: 2024-01-01
Aditya K Gupta, Avantika Mann, Kimberly Vincent, William Abramovits
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引用次数: 0

摘要

用于肌肉注射的DAXXIFYTM(daxibotulinumtoxinA-lanm)最近获得批准,可用于暂时改善成年患者与皱眉肌和/或前突肌活动相关的中度至重度睑纹(GLs)。DaxibotulinumtoxinA for Injection(DAXI)含有纯化的150-kDA A型肉毒毒素(BoNTA),并配以新型多肽赋形剂,该赋形剂带正电荷,有助于将神经毒素与带负电荷的神经元膜结合,延长持续时间。DAXI 的有效性在两项三期试验 SAKURA 1 和 SAKURA 2 中进行了评估,试验采用随机、双盲、安慰剂对照设计。主要终点(治疗成功)是第4周GLs严重程度改善≥2点的综合临床结果(研究者和受试者)。在 SAKURA 1 中,接受 DAXI 治疗的受试者治疗成功率为 74%(148/201),接受安慰剂治疗的受试者治疗成功率为 0%。在 SAKURA 2 中,接受 DAXI 治疗的受试者治疗成功率为 74%(152/205),接受安慰剂治疗的受试者治疗成功率为 0%。SAKURA 3 是一项开放标签研究,共有 2,691 名参与者接受了连续三个治疗周期的治疗。这些患者是从 SAKURA 1 或 SAKURA 2 试验中招募的,或者是新加入研究并接受了 DAXI 治疗的患者。三个连续治疗周期的治疗成功率分别为 73.2%、77.7% 和 79.6%。格拉贝拉复合体的推荐剂量为 40 单位,按传统方法在五个注射部位(双侧内侧和外侧皱纹肌以及前额肌各注射一次)进行五次肌肉注射。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
DAXXIFYTM (DaxibotulinumtoxinA-Lanm) for Injection, for Intramuscular Use.

DAXXIFYTM (daxibotulinumtoxinA-lanm) for intramuscular injection was recently approved for temporary improvement in the appearance of the moderate to severe glabellar lines (GLs) associated with corrugator and/or procerus muscle activity in adult patients. DaxibotulinumtoxinA for Injection (DAXI) includes a purified 150-kDA botulinum toxin Type A (BoNTA) formulated with a novel peptide excipient that is positively charged and helps to bind the neurotoxin to negatively charged neuronal membrane for a longer duration. The effectiveness of DAXI was evaluated in two phase 3 trials, SAKURA 1 and SAKURA 2, using a randomized, double-blind, placebo-controlled design. The primary endpoint (treatment success) was a composite clinical outcome (investigator and subjects) of ≥2-point improvement in severity of GLs at week 4. In SAKURA 1, the treatment success was 74% (148/201) in subjects treated with DAXI and 0% in subjects treated with placebo. In SAKURA 2, the treatment success was 74% (152/205) in subjects treated with DAXI and 0% in subjects treated with placebo. An open-label study, SAKURA 3, included 2,691 participants, who underwent three consecutive treatment cycles. These individuals were recruited from either SAKURA 1 or SAKURA 2 trials, or were new to the study and received DAXI. Treatment success proportions were 73.2%, 77.7%, and 79.6% across the three consecutive treatment cycles. The recommended dose is 40 units for the Glabellar-complex divided in traditional five intramuscular injections at five injection sites (medial and lateral corrugator bilaterally and one injection in the procerus muscle).

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