Advice

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.

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Medicine details

Medicine name:
eslicarbazepine acetate (Zebinix)
SMC ID:
592/09
Indication:
Adjunctive therapy in adults with partial-onset seizures
Pharmaceutical company
Eisai Ltd
BNF chapter
Central nervous system
Submission type
Full
Status
Not recommended
Date advice published
18 January 2010