following a full submission assessed under orphan equivalent process:
mexiletine (Namuscla®) is not recommended for use within NHSScotland.
Indication under review: for the symptomatic treatment of myotonia in adult patients with non-dystrophic myotonic disorders.
In a short-term, phase III, crossover study, mexiletine significantly improved muscle stiffness compared with placebo when measured on a visual analogue scale.
The submitting company’s justification of the treatment’s cost in relation to its health benefits was not sufficient and in addition the company did not present a sufficiently robust economic analysis to gain acceptance by SMC.
This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
- Medicine name:
- mexiletine hydrochloride (Namuscla)
- SMC ID:
For the symptomatic treatment of myotonia in adult patients with non-dystrophic myotonic disorders (NDM).
- Pharmaceutical company
- Lupin Healthcare
- BNF chapter
- Central nervous system
- Submission type
- Not recommended
- Date advice published
- 09 March 2020