Brin Mitchell F
Allergan, LLC, 2525 Dupont Drive, Irvine, CA 92612-1599, USA.
Toxicon. 2009 Oct;54(5):668-74. doi: 10.1016/j.toxicon.2009.01.015. Epub 2009 Jan 28.
Since the late 1970s, local injections of BoNT have provided clinical benefit for patients with inappropriately contracting muscles with or without pain or sensory disturbance. Marketing authorization for some BoNTs, depending on country, include core indications of dystonia (blepharospasm and cervical dystonia), large muscle spastic disorders (not yet approved in the United States, e.g., adult post-stroke spasticity and equinus foot deformity), hyperhidrosis and aesthetic. Subsequent development has extended to selected conditions characterized by recurrent or chronic pain (migraine headache), and urologic indications (neurogenic/idiopathic overactive bladder; prostate hyperplasia), with multiple additional opportunities available. Portfolio management requires a careful individual opportunity assessment of scientific and technical aspects (basic science foundation, potential to treat unmet medical need, product-specific risk in specific populations, therapeutic margin/safety profile, and probability of successful registration pathway). This article describes ongoing development targets for BOTOX.
自20世纪70年代末以来，局部注射肉毒毒素已为肌肉不适当收缩的患者带来临床益处，无论患者有无疼痛或感觉障碍。根据国家不同，一些肉毒毒素的上市许可包括肌张力障碍（眼睑痉挛和颈部肌张力障碍）、大肌肉痉挛性疾病（美国尚未批准，例如成人中风后痉挛和马蹄足畸形）、多汗症和美容等核心适应症。后续的研发已扩展到以复发性或慢性疼痛（偏头痛）以及泌尿科适应症（神经源性/特发性膀胱过度活动症；前列腺增生）为特征的特定病症，还有多个其他机会。产品组合管理需要对科学和技术方面进行仔细的个体机会评估（基础科学基础、满足未满足医疗需求的潜力、特定人群中产品特有的风险、治疗窗/安全性概况以及成功注册途径的可能性）。本文介绍了保妥适正在进行的研发目标。
