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News From the Food and Drug Administration
January 7, 2020

Novel Alternative for Partial-Onset Seizures

JAMA. 2020;323(1):18. doi:10.1001/jama.2019.20952

The novel antiepileptic medication cenobamate has received approval for adults who have partial-onset seizures. The drug offers a new alternative for the more than one-third of patients with epilepsy whose seizures aren’t controlled despite treatment with 1 or more antiepileptic drugs.

Marketed as Xcopri, cenobamate is a tetrazole alkyl carbamate derivative that has shown broad anticonvulsant activity in preclinical epilepsy studies. It’s been evaluated in 2 clinical trials, 1 involving 222 patients that remains ongoing.

In the other trial, 437 patients were randomized to receive 100 mg, 200 mg, or 400 mg of cenobamate or placebo. The study was designed with a 6-week titration phase and a 12-week maintenance phase. At the end of the 18 weeks, seizure frequency was reduced by 24% in the placebo group, 35.5% in the 100-mg group, and 55% in both the 200-mg and 400-mg groups. In addition, the proportion of patients whose seizure frequency decreased by 50% or more during the maintenance phase was 25% in the placebo group, 40% in the 100-mg group, 56% in the 200-mg group, and 64% in the 400-mg group.

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