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Brivaracetam: a newly approved medication for epilepsy

Joel M Oster

Joel M Oster

*Author for correspondence: Tel.: +1 617 636 5848; Fax: +1 617 636 8199;

E-mail Address: joster@tuftsmedicalcenter.org

Department of Neurology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA 02111, USA

Lahey Clinic, Burlington, MA 02111, USA

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Published Online:8 Oct 2018https://doi.org/10.2217/fnl-2015-0002

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Abstract

Brivaracetam (BRV) in both the USA and EU was developed as a novel molecule for the adjunctive treatment of partial-onset (focal) seizures in patients ≥16 years of age and as of September 2017 was approved for use as monotherapy in the USA uniquely as an antiseizure medication that may be prescribed without a dose finding uptitration. This article reviews BRV's pharmacology, efficacy, safety and adverse event profiles, along with the relevant and noted regulatory hurdles in the USA and the EU. Available postmarketing data will also be summarized. Approximately 3000 patients were studied over about 9 years in the clinical trial program illustrating that BRV has efficacy at 50–200 mg/day with an acceptable adverse event profile.

Keywords:

Papers of special note have been highlighted as: • of interest; •• of considerable interest

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Vol. 14, No. 3

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History

Received 3 December 2015

Accepted 5 September 2018

Published online 8 October 2018

Published in print August 2019

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Financial & competing interests disclosure

The author was principal investigator (PI) on a number of Clinical Trials, including with UCB, had been consultant speaker previously but not after 2009. The authors have 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 apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Company review

In addition to the peer-review process, with the author's consent, the manufacturer of the product discussed in this article was given the opportunity to review the manuscript for factual accuracy. Changes were made by the author at their discretion and based on scientific or editorial merit only. The author maintained full control over the manuscript, including content, wording and conclusions.

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