Movement Disorders Section, Department of Neurology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany.
Botulinum Toxins Laboratory, Department of Bacteriology, University of Wisconsin, Madison, WI, USA.
J Neural Transm (Vienna). 2022 Jun;129(5-6):829-833. doi: 10.1007/s00702-022-02494-5. Epub 2022 Apr 9.
Although botulinum toxin (BT) is now being used in a large number of different indications in numerous medical specialties, there is still dynamic and rapid development. Treatment algorithms were improved by the introduction of BT short-interval therapy, BT high-dose therapy and improved dosing guidelines. Ultrasound guidance may be helpful in special situations. New indication areas including depression and inflammatory processes are being explored. Drug development projects are mainly focusing on onabotulinumtoxinA analogues, some are addressing liquid preparations and modifications of BT's duration of action. Recombinant BT may simplify production processes. Cell-based assays for potency measurement will soon be required by registration authorities. Treatment algorithms will be further refined and indications will be expanded. New indication areas are still uncertain. BT type A will remain the drug substance of choice. Removal of complexing proteins seems logical. Whether there is a need for BT drugs with modified duration of action and for liquid preparations, is unclear. Bringing BT therapy to those who need it, is the biggest challenge. Current high-price business models need to be changed, either by employing a biosimilar registration approach or by referring to companies from countries where business models are based on different cost structures.
尽管肉毒毒素（BT）现在在众多医学专业的大量不同适应症中得到应用，但它仍在不断发展和快速发展。通过引入 BT 短程治疗、BT 高剂量治疗和改进的剂量指南，治疗算法得到了改善。超声引导在特殊情况下可能会有所帮助。新的适应症领域，包括抑郁症和炎症过程，正在探索中。药物开发项目主要集中在肉毒毒素 A 类似物上，其中一些项目针对的是液体制剂和 BT 作用持续时间的改进。重组 BT 可能会简化生产工艺。登记管理机构很快将要求进行基于细胞的效力测定。治疗算法将进一步细化，适应症将扩大。新的适应症领域仍不确定。BT 类型 A 将仍然是首选的药物物质。去除络合蛋白似乎是合理的。是否需要具有改进作用持续时间的 BT 药物和液体制剂尚不清楚。为有需要的人提供 BT 治疗是最大的挑战。目前的高价商业模式需要改变，要么采用类似物的注册方法，要么参考那些商业模式基于不同成本结构的国家的公司。
