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Archived: eslicarbazepine acetate (Zebinix)


Following a full submission

eslicarbazepine acetate (Zebinix) is not recommended for use within NHS Scotland for adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation.

The efficacy of eslicarbazepine acetate in terms of the reduction in standardised seizure frequency was demonstrated in three 12-week placebo-controlled studies. There are no clinical studies comparing eslicarbazepine acetate to other anti-epileptic drugs, and a mixedtreatment indirect comparison was undertaken to show equivalent efficacy of eslicarbazepine acetate and a single other anti-epileptic drug.

The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC.

The licence holder has indicated their intention to resubmit.

Drug Details

Drug Name: eslicarbazepine acetate (Zebinix)
SMC Drug ID: 592/09
Manufacturer: Eisai Ltd
Indication: Adjunctive therapy in adults with partial-onset seizures
BNF Category:
Sub Category: 4.8 Antiepileptic drugs
Submission Type: Full submission
Status: Not Recommended
Date Advice Published: 18 January 2010

Current Advice

Resubmission 8 November 2010