Phase 3 studies of Stedesa for the treatment of seizures
Sunovion announced data from two Phase 3 studies of Stedesa (eslicarbazepine acetate [ESL]) in the treatment of patients with a history of partial-onset seizures. The two studies were double-blind trials evaluating the undesirable metabolic effects by prolonged treatment with antiepileptic drugs (AEDs). The studies analyzed the changes in weight, glucose, alanine transaminase (ALT), aspartate transaminase (AST) , and lipid fractions (TC; LDL-C; HDL-C; TRIG) when using Stedesa as adjunctive therapy to 1-3 concomitant AEDs. These metabolic parameters were analyzed using pooled data from two Phase 3 studies in subjects taking Stedesa compared with placebo. Mean changes from baseline to the end of the double-blind period (14 weeks) in the metabolic parameters were small in the placebo and ESL groups. The incidence of potentially clinically significant (PCS) events related to glucose, AST, and ALT were similar across groups. Small differences in PCS abnormal lipid parameters and weight increase of ≥7% from baseline were observed between the ESL dose groups and the placebo group.
Additionally, Levetiracetam (LEV) was identified as a commonly used concomitant antiepileptic drug in the two Phase 3 studies. Of the 790 subjects included in the efficacy analysis, 96 (12.1%) used AEDs including LEV. The least square mean difference from placebo in standardized seizure frequency in subjects using AEDs including LEV was 2.9, 3.2, and 2.7 compared to 0.6, 2.0, and 2.2 in those subjects using AEDs other than LEV for ESL 400, 800, and 1200 mg, respectively.
Stedesa is a novel voltage-gated sodium channel blocker that has been designed to reduce the frequency of partial-onset seizures.
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