Eslicarbazepine acetate

(Aptiom®)

Eslicarbazepine acetate

Drug updated on 9/4/2024

Dosage FormTablet (oral; 200 mg, 400 mg, 600 mg, 800 mg)
Drug ClassAnticonvulsants
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of partial-onset seizures in patients 4 years of age and older.

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Summary
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  • Aptiom (eslicarbazepine acetate) is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
  • This summary is based on the review of eight systematic review(s)/meta-analysis(es). [1-8]
  • Eslicarbazepine acetate (ESL) was generally effective in reducing seizure frequency and achieving a ≥50% responder rate, particularly in adults with focal epilepsy. However, it was less effective compared to cenobamate (CNB) and brivaracetam in achieving seizure freedom.
  • ESL showed dose-dependent effectiveness in adults, with higher effectiveness observed at 800 mg/day, but it did not significantly improve outcomes in children, where higher dropout rates and lower effectiveness were noted compared to other antiseizure medications.
  • ESL was associated with fewer adverse events compared to placebo but had higher treatment-emergent adverse events (TEAEs) and dropout rates due to adverse events compared to other antiseizure medications (ASMs) such as brivaracetam and lacosamide.
  • In children, ESL showed higher dropout rates due to adverse events compared to other ASMs, and at a higher dose (1200 mg/d), it significantly increased the risk of severe adverse events.
  • There is no population types or subgroups information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Aptiom (eslicarbazepine acetate) Prescribing Information.2019Sunovion Pharmaceuticals Inc. Marlborough, MA

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines