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Eslicarbazepine Acetate Monotherapy: A Review in Partial-Onset Seizures

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Abstract

Eslicarbazepine acetate (Aptiom®) is a once-daily, orally administered antiepileptic drug (AED) approved previously in the EU, USA and several other countries for use as adjunctive therapy for the treatment of partial-onset seizures. Based on the findings of two randomized, dose-blinded, conversion-to-monotherapy phase III trials in patients with uncontrolled partial epilepsy, the US license for eslicarbazepine acetate has recently been expanded to include use as monotherapy for partial-onset seizures. The pivotal trials demonstrated that seizure control following conversion from other AEDs was superior for eslicarbazepine acetate monotherapy (1200 or 1600 mg once daily) compared with a pseudo-placebo historical control. Other efficacy outcomes appeared to support the benefit of treatment, with up to 10 % of patients remaining seizure free and up to 46 % of patients experiencing a ≥50 % reduction from baseline in standardized seizure frequency during the monotherapy periods of the trials. Eslicarbazepine acetate monotherapy was generally well tolerated, with most treatment-emergent adverse events being mild to moderate in severity. Its tolerability profile was generally consistent with the established profile of the drug based on its use as adjunctive therapy. Thus, once-daily eslicarbazepine acetate, either as monotherapy or adjunctive therapy, represents a useful option for the treatment of patients with partial-onset seizures. The recent licensing of the drug in the USA as monotherapy expands the range of treatment options for patients with partial-onset seizures and increases the opportunity to tailor therapy to the individual patient.

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Acknowledgments

During the peer review process, the manufacturer of eslicarbazepine acetate was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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    Matt Shirley & Sohita Dhillon

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  1. Matt Shirley
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Correspondence to Matt Shirley.

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The preparation of this review was not supported by any external funding.

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Matt Shirley and Sohita Dhillon are salaried employees of Adis/Springer, are responsible for the article content and declare no relevant conflicts of interest.

Additional information

The manuscript was reviewed by: M. L. Barker - Haliski, Department of Pharmacy, University of Washington, Seattle, WA, USA; W. E. Rosenfeld, The Comprehensive Epilepsy Care Center for Children and Adults, St. Louis, MO, USA; L. Sander, Department of Clinical and Experimental Epilepsy, University College London Institute of Neurology, London, UK.

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Shirley, M., Dhillon, S. Eslicarbazepine Acetate Monotherapy: A Review in Partial-Onset Seizures. Drugs 76, 707–717 (2016). https://doi.org/10.1007/s40265-016-0570-7

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