following a second re-submission:
botulinum toxin type A (Botox®) is accepted for use within NHSScotland.
Indication under review: focal spasticity, including the treatment of wrist and hand disability due to upper limb spasticity associated with stroke in adults.
In a placebo-controlled study, botulinum toxin type A was significantly superior to placebo in terms of the disability assessment scale and efficacy was maintained across repeated injections in an open-label extension study with a duration of one year.
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Medicine details
- Medicine name:
- clostridium botulinum type A neurotoxin (Botox)
- SMC ID:
- 80/03
- Indication:
Focal spasticity of the wrist and hand associated with stroke in adults.
- Pharmaceutical company
- Allergan Ltd
- BNF chapter
- Central nervous system
- Submission type
- Resubmission
- Status
- Accepted
- Date advice published
- 07 March 2011
The use of botulinum toxin type A in upper limb spasticity has become established according to local protocols. An extension to the licensed indication to remove the limitation to patients post stoke will not be assessed by SMC. Consequently, no SMC advice will be issued for the use of botulinum toxin type A (Botox) in the full licensed indication “focal spasticity including upper limb spasticity in adults”. Use of botulinum toxin type A in upper limb spasticity should be in line with local formulary decisions.