Magazine article Drug Topics

New Adjunctive Treatment for Partial-Onset Seizures

Magazine article Drug Topics

New Adjunctive Treatment for Partial-Onset Seizures

Article excerpt


Eslicarbazepine acetate (Aptiom, Sunovion Pharmaceuticals, Inc.) was approved by FDA on November 8, 2013, as an adjunctive treatment of partial-onset seizures in adults. After oral administration, eslicarbazepine acetate, a prodrug, is extensively metabolized through first-pass metabolism to the major active metabolite, eslicarbazepine. Eslicarbazepine is a voltage-gated sodium channel inhibitor.


FDA approval of eslicarbazepine acetate was based on the findings of three double-blind, placebo-controlled trials. An eight-week baseline assessment of seizure frequency identified participants for inclusion. Participants had partial-onset seizures with or without secondary generalization and were not adequately controlled on concomitant antiepileptic chugs. Oxcaibazepine use was not allowed during the studies. Participants who demonstrated an average of four or more seizures within 28 days without a seizurefree period for more than 21 days continued on to the titration and maintenance phases of study (median of eight seizures per 28 days). Two studies compared 400-mg, 800-mg, and 1,200mg doses to placebo. The third study compared 800 mg and 1,200 mg to placebo. Seizure frequency during the maintenance period served as the primary efficacy end point for all the studies. Secondary efficacy end points included the proportion of participants experiencing a 50% reduction in seizure frequency over four weeks during the 12-week maintenance phase and the overall change in seizure frequency from baseline.

Overall, the three studies demonstrated a significant doserelated treatment efficacy compared to placebo. The 1,200-mg dosage demonstrated efficacy in all three studies and the 800mg dosage demonstrated efficacy in two studies. The 400-mg dose failed to demonstrate significant treatment efficacy. Fortyone percent of patients receiving 1,200 mg and 32% of patients receiving 800 mg of eslicarbazepine acetate experienced a minimum 50% reduction in seizure frequency during the maintenance phase compared to 22% of participants receiving placebo. In all studies, participants administered 800 mg or 1200 mg of eslicarbazepine acetate experienced a greater than median percent reduction from baseline frequency of seizures compared to those receiving placebo.


The most common adverse reactions associated with eslicarbazepine acetate include dizziness, somnolence, headache, nausea, vomiting, fatigue, vertigo, ataxia, tremor, and visual disturbances (blurred vision, diplopia). The rate of study discontinuation demonstrated a dose-related relationship. …

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