韩国SK生物制药苯巴那酯获美国FDA批准治疗成人部分发作性癫痫

South Korea's SK Biopharmaceuticals and its U.S. subsidiary SK Life Sciences recently jointly announced that the U.S. Food and Drug Administration (FDA) has approved cenobamate tablets for the treatment of partial-onset epilepsy in adults. In 2 adequate and well-controlled clinical studies, phebanate significantly reduced the frequency of partial-onset epilepsy, with up to 20% of patients achieving zero seizures during the maintenance period.

The mechanism by which phenobarnate exerts its therapeutic effect in patients with partial-onset epilepsy is unclear. However, phebanate can inhibit voltage-gated sodium currents to reduce repetitive nerve discharges, and can also inhibit the repetitive release of electrical impulses in nerve cells by regulating γ-aminobutyric acid (GABAA) ion channels.

In a global, randomized, double-blind, placebo-controlled study, when administered at a dose of 200 mg·d-1, the median seizure frequency was reduced by 56% in the phenobarnate treatment group, compared with 22% in the placebo group; during the maintenance period, 28% of patients in the phenobarnate treatment group reported zero seizures, compared with 9% in the placebo group. The results of another global, multi-center, open-label, safety study showed that when the doses were 100, 200, and 400 mg·d-1, the phenobanate treatment group reduced the median seizure frequency by 36%, 55%, and 55%, respectively, while the placebo group reduced it by 24%; during the maintenance period, 4%, 11%, and 21% of patients in the three dosage groups reported zero seizures, respectively, compared with 1% in the placebo group.

Observed in the experiment were shortening of the QT interval of the electrocardiogram, systemic symptoms, suicidal behavior tendencies, multi-organ hypersensitivity reactions, neurological adverse reactions, discontinuation of anti-epileptic drugs, eosinophilia, etc.

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