Abstract
Brivaracetam (BRV) is a new antiepileptic drug structurally related to levetiracetam but with a 15 to 30-fold increased affinity for the same molecular target, namely the SV2A ligand. BRV is currently under Phase III development as adjunctive treatment for partial onset seizures but data from some Phase III suggest also potential efficacy for primary generalized seizures. Although two studies are negative for the primary efficacy endpoint, global results seem to suggest a wide spectrum of efficacy for both partial onset and primary generalized seizures and a favourable safety and pharmacokinetic profile. This article is aimed at providing a comprehensive overview of current evidence about BRV in the treatment of epilepsy taking into account emerging concerns regarding clinical trials in epilepsy.
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Financial & competing interests disclosure
M Mula has received, in the past, travel grants or consultancy fees from Pfizer and UCB Pharma. When the paper was written, the author’s affiliation was the following: Division of Neurology, Trinity Hospital, Borgomanero, Italy. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript other than those disclosed.
No writing assistance was utilized in the production of this manuscript.
Key issues
Brivaracetam is a new antiepileptic drug structurally related to levetiracetam but with a 15- to 30-fold increased affinity for the same molecular target, namely the SV2A ligand.
Brivaracetam is currently under Phase III development as adjunctive treatment for partial-onset seizures, but data from Phase IIb and some Phase III studies are already available.
Available results seem to suggest a favorable safety and pharmacokinetic profile and a therapeutic window between 50 and 150 mg daily.
The mechanism of action and preliminary efficacy results from Phase III trials suggest a wide spectrum of efficacy with a potential in primary generalized seizures.