Eslicarbazepine acetate

(Aptiom®)

Aptiom®

Drug updated on 7/25/2024

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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  • Eslicarbazepine acetate (Aptiom) is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
  • The information was derived from 8 systematic reviews/meta-analyses studies.
  • In network meta-analysis, eslicarbazepine acetate showed effectiveness in decreasing seizure frequency but had a moderate safety profile compared to other ASMs like cenobamate, brivaracetam, lacosamide, and perampanel. Non-invasive brain stimulation therapies were less effective than ASMs.
  • Real-world longitudinal studies demonstrated that eslicarbazepine acetate as initial or early monotherapy resulted in high seizure-free rates at 6 months (64.6%) and 12 months (56.6%), with retention rates at 95% and adverse events leading to discontinuation in some cases among adults with focal epilepsy.
  • A Cochrane network meta-analysis could not include individual participant data for eslicarbazepine acetate; however, other drugs like lamotrigine performed better regarding treatment failure and achieving remission across children and adults with focal or generalized tonic-clonic seizures.
  • Systematic review findings indicate that while eslicarbazepine acetate has acceptable safety profiles as an add-on therapy for drug-resistant focal epilepsy, it shows higher dropout rates due to adverse events when used among pediatric populations compared to drugs like lamotrigine and levetiracetam.

Product Monograph / Prescribing Information

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

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines