Clinical Pharmmacology of Botulinum Toxic A

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This document summarizes the clinical pharmacology of botulinum toxin A. It discusses how botulinum toxin works by inhibiting the release of acetylcholine at neuromuscular junctions, its mechanism of action on cleaving proteins involved in vesicle fusion, and its temporary effects that require repeated injections. The document also outlines botulinum toxin's introduction as a treatment for muscle overactivity and facial aesthetics, its time course of onset and duration of effects, dosing in units, and potential adverse events being primarily localized muscle weakness.

Technology Health & Medicine

Clinical Pharmacology
of Botulinum Toxin A
Sunisa Sintuwong, M.D.
Mettapracharak (Wat Raikhing) Hospital

Sunday, August 26, 2012 1

• introduction
• synthesis and structure of Botulinum
neurotoxins
• mechanism of action
• clinical pharmacology

Sunday, August 26, 2012 2

introduction
• ﬁrst used for treatment of strabismus and
blepharospasm (muscular overactivity)
• then use in facial aesthetics
• most popular non-surgical aesthetic
procedure in USA
• only BOTOX is currently approved for
cosmetic use in USA

Sunday, August 26, 2012 3

Synthesis and Structure
of Botulinum neurotoxins

• “proteins” produced by different clostridial
bacterial species
• related to tetanus toxin
• progenitor toxin and associated proteins
• different bacterial strains -> different
botulinum neurotoxin serotype (type
A,B,C1,D,E,F,G)

Sunday, August 26, 2012 4

• various serotypes form different complex
sizes
• only type A forming largest complex (900
kd)
• active neurotoxin 150 kd
• and cleaved in an active dichain: 100 kd
heavy chain and 50 kd light chain

Sunday, August 26, 2012 5

Mechanism of Action
• inhibition of acetylcholine release
• inhibit exocytosis of Ach at NMJ
• begins when BTX bind cholinergic receptor
on cholinergic nerve terminals
• BTX molecules internalized into the cell
• heavy and light chain separated
• light chains act as an enzyme: cleaving bond
of proteins needed for exocytosis of Ach
(SNARE)
Sunday, August 26, 2012 6

• SNARE (Soluble N-ethyl-maleimide-
sensitive factor attachment protein
receptor)
• inhibit Ach release then reduce muscular
contraction
• results in nerve sprout at NMJ and release
Ach (temporary)
• temporary and reversible
• needs repeated injection and dose and
injection site adjustment

Sunday, August 26, 2012 7

• multistep process: time lag btw exposure to
toxin and onset of muscle weakness
• also inhibit release of Ach of autonomic
terminals: Rx sialorrhea and primary
axillary hyperhidrosis
• Kozaki et al and Dong et al: identiﬁed
synaptotagmin protein with gangliosides
(GT1b) receptor for BTX type B and G

Sunday, August 26, 2012 8

Clinical Pharmacology

• Unit Doses
• units of biologic activity (U)
• doses not standardized among different
BTX products

Sunday, August 26, 2012 9

Time Course of Clinical
Effects

• BTX type A injected IM
• onset 3-7 days
• duration 3-5 months

Sunday, August 26, 2012 10

Clinical Adverse Events

• most focal muscle weakness
• systemic side effects: rare (BOTOX
information)

Sunday, August 26, 2012 11

Why Dysport®? Dysport is a simple, effective, non-surgical treatment that works by relaxing facial muscles on the forehead, thereby reducing and smoothing away frown-lines and wrinkles. Dysport is supported by over a decade of clinical experience. Dysport was developed in the United Kingdom in the early 1990s to successfully treat a number of neurological and ophthalmic conditions. Since that time, with an increased understanding of the uses of Dysport, thousands of treatments have been safely and effectively performed for a variety of conditions ranging from frown lines to axillary hyperhidrosis (excessive sweating under the armpits). In New Zealand, Dysport has been used for many years, by eye specialists and neurologists, to treat nervous tics and muscle spasms of the face and neck. In fact, Dysport has been available in New Zealand for over 12 years for treating neuro-muscular conditions and was the first botulinum toxin Type A to be approved in New Zealand for medical use. Dysport is manufactured in Britain by Ipsen Limited.

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Clinical Pharmmacology of Botulinum Toxic A

1. Clinical Pharmacology of Botulinum Toxin A Sunisa Sintuwong, M.D. Mettapracharak (Wat Raikhing) Hospital Sunday, August 26, 2012 1

2. • introduction • synthesis and structure of Botulinum neurotoxins • mechanism of action • clinical pharmacology Sunday, August 26, 2012 2

3. introduction • ﬁrst used for treatment of strabismus and blepharospasm (muscular overactivity) • then use in facial aesthetics • most popular non-surgical aesthetic procedure in USA • only BOTOX is currently approved for cosmetic use in USA Sunday, August 26, 2012 3

4. Synthesis and Structure of Botulinum neurotoxins • “proteins” produced by different clostridial bacterial species • related to tetanus toxin • progenitor toxin and associated proteins • different bacterial strains -> different botulinum neurotoxin serotype (type A,B,C1,D,E,F,G) Sunday, August 26, 2012 4

5. • various serotypes form different complex sizes • only type A forming largest complex (900 kd) • active neurotoxin 150 kd • and cleaved in an active dichain: 100 kd heavy chain and 50 kd light chain Sunday, August 26, 2012 5

6. Mechanism of Action • inhibition of acetylcholine release • inhibit exocytosis of Ach at NMJ • begins when BTX bind cholinergic receptor on cholinergic nerve terminals • BTX molecules internalized into the cell • heavy and light chain separated • light chains act as an enzyme: cleaving bond of proteins needed for exocytosis of Ach (SNARE) Sunday, August 26, 2012 6

7. • SNARE (Soluble N-ethyl-maleimide- sensitive factor attachment protein receptor) • inhibit Ach release then reduce muscular contraction • results in nerve sprout at NMJ and release Ach (temporary) • temporary and reversible • needs repeated injection and dose and injection site adjustment Sunday, August 26, 2012 7

8. • multistep process: time lag btw exposure to toxin and onset of muscle weakness • also inhibit release of Ach of autonomic terminals: Rx sialorrhea and primary axillary hyperhidrosis • Kozaki et al and Dong et al: identiﬁed synaptotagmin protein with gangliosides (GT1b) receptor for BTX type B and G Sunday, August 26, 2012 8

9. Clinical Pharmacology • Unit Doses • units of biologic activity (U) • doses not standardized among different BTX products Sunday, August 26, 2012 9

10. Time Course of Clinical Effects • BTX type A injected IM • onset 3-7 days • duration 3-5 months Sunday, August 26, 2012 10

11. Clinical Adverse Events • most focal muscle weakness • systemic side effects: rare (BOTOX information) Sunday, August 26, 2012 11

Clinical Pharmmacology of Botulinum Toxic A

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Clinical Pharmmacology of Botulinum Toxic A