Clinical Pharmacology of Botulinum Toxin Drugs
Botulinum toxin (BT) has changed from a deadly poison to a novel therapeutic principle for a large number of disorders in many medical areas.
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Contents 1 Introduction 2 Therapeutic Mode of Action 3 Time Course of Action 4 Target Tissues 5 General Pharmacological Profile 6 Adverse Effects 7 Interactions 8 Potency Labelling 9 Antigenicity 10 Therapeutic Preparations References
Abstract
Botulinum toxin (BT) has changed from a deadly poison to a novel therapeutic principle for a large number of disorders in many medical areas. BT drugs are special in many ways: they are biologicals, their active ingredient BT is not patentable, their spectrum of clinical applications is extremely broad, their dose range is enormous, their mode of action is local and their life cycles are special. This review covers BT’s therapeutic mode of action, time course of action, target tissues, pharmacological profile, adverse effects, interactions, potency labelling and antigenicity as well as BT’s therapeutic preparations.
D. Dressler (*) Movement Disorders Section, Department of Neurology, Hannover Medical School, Hannover, Germany e-mail: [email protected] # Springer Nature Switzerland AG 2019 Handbook of Experimental Pharmacology, https://doi.org/10.1007/164_2019_273
D. Dressler
Keywords
Adverse effects · Antigenicity · Botulinum toxin · Clinical pharmacology · Interactions · Mode of action · Pharmacological profile · Potency labelling · Target tissues · Therapeutic preparations · Time course
1
Introduction
Botulinum toxin (BT) has made one of the most remarkable transitions in the history of mankind: once infamous as a food safety hazard and a means of biological warfare it is now a drug for a large number of disorders for many of which it has revolutionised their treatment. BT drugs are special in many ways: As biologicals they are not only specified by their chemicophysical properties alone, but also by their steric confirmation which is heavily influenced by the manufacturing process and handling conditions. Comparing biologicals is challenging and has to consider many parameters. Nevertheless, also biologicals can and need to be compared with respect to efficacy, adverse effects and economics. BT as a natural compound cannot be protected by patents. Intellectual property protection is mainly gained by the BT drug’s registration status. This generates very special drug life cycles and the option of alternative registration pathways through biosimilarity approval. This may dramatically influence the future development of BT drugs. The broad spectrum of clinical applications generates enormous dose ranges leading to serious pricing issues. As a strictly local agent BT drugs require specific registration pathways. This review covers BT’s therapeutic mode of action, time course of action, target tissues, pharmacological profile, adverse effects, interactions, potency labelling and antigenicity as well as BT’s therapeutic preparations.
2
Therapeutic Mode of Action
Botulinum neurotoxin (BNT) is blocking the SNARE protein-mediated excretion process of acetylcholine from cholinergic neurons. BT’s binding, internalisation and intracellular action involve highly complex a
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