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stiripentol (Diacomit)

Advice

following a resubmission considered under the orphan equivalent process:

stiripentol (Diacomit®) is accepted for use within NHS Scotland.

Indication under review: in conjunction with clobazam and valproate as adjunctive therapy of refractory generalised tonic-clonic seizures in patients with severe myoclonic epilepsy in infancy (SMEI; Dravet’s syndrome) whose seizures are not adequately controlled with clobazam and valproate.

Adjunctive treatment with stiripentol, compared with placebo, significantly reduced seizure frequency in children aged at least three years with SMEI who had at least four seizures per month despite treatment with clobazam and valproate. 
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.

Drug Details

Drug Name: stiripentol (Diacomit)
SMC Drug ID: 524/08
Manufacturer: BIOCODEX
Indication: In conjunction with clobazam and valproate as adjunctive therapy of refractory generalised tonic-clonic seizures in patients with severe myoclonic epilepsy in infancy (SMEI; Dravet’s syndrome) whose seizures are not adequately controlled with clobazam and valproate.
BNF Category:
Submission Type: Resubmission
Status: Accepted
Date Advice Published: 11 September 2017

Archived Advice

Full submission 12 January 2009

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