following a resubmission assessed under the orphan process:
mexiletine (Namuscla®) is accepted 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.
This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.
This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Medicine details
- Medicine name:
- mexiletine (Namuscla)
- SMC ID:
- SMC2307
- Indication:
Symptomatic treatment of myotonia in adult patients with non-dystrophic myotonic disorders.
- Pharmaceutical company
- Lupin Healthcare
- BNF chapter
- Central nervous system
- Submission type
- Resubmission
- Status
- Accepted
- Date advice published
- 07 December 2020