Phase III results of Zebinix in epilepsy published in Epilepsia.- Bial and Eisai.

Results of a phase III study published in Epilepsia has demonstrated Zebinix (esclicarbazeptine acetate), from Bial and Eisai, is non-inferior to twice-daily controlled released carbamazepine in the treatment of newly diagnosed focal epilepsy patients. The Phase III study, which included 815 patients, met its primary endpoint of non-inferiority compared with the standard of care treatment in the proportion of patients who were seizure-free for the study period of 26-weeks.

Additionally, the monotherapy was found to be well-tolerated. It showed that 71.1 percent of patients on Zebinix and 75.6 percent of those on controlled-release carbamazepine were seizure-free for six months or more, while for one year the figures were 64.7 percent 70.3 percent, respectively. Adverse event rates were similar in the two treatment groups, though Zebinix had lower rates of discontinuation due to adverse events.

See: "Efficacy and safety of eslicarbazepine acetate versus controlled-release carbamazepine monotherapy in newly diagnosed epilepsy: A phase III double-blind, randomized, parallel-group, multicenter study" Eugen Trinka et al. Epilepsia online: 25 JAN 2018 | DOI: 10.1111/epi.13993