ONCE-DAILY eslicarbazepine acetate (Zebinix®, Eisai, Tokyo, Japan) is non-inferior to the current standard of care, twice-daily controlled-released carbamazepine, for newly-diagnosed focal epilepsy patients, according to the results of a study. The pivotal Phase III monotherapy trial was shown to have met the primary endpoint of non-inferiority for eslicarbazepine acetate through the number of patients shown to be seizure-free throughout the 26-week evaluation period.
Of the 388 patients treated with eslicarbazepine acetate, 276 (71.1%) were seizure-free for 6 months or more; this was achieved in 300 of the 397 participants given carbamazepine (75.6%) at the last evaluated dose. Seizure-freedom rates at 1-year were 64.7% and 70.3% with eslicarbazepine acetate and carbamazepine, respectively.
Eslicarbazepine acetate was also shown to be well-tolerated in patients, with discontinuation rates lower with this drug than with carbamazepine (14.0% versus 18.4%, respectively). Treatment-emergent adverse events (TEAEs) occurred at similar rates in both eslicarbazepine acetate and carbamazepine (76.3% versus 79.6%, respectively), with the most frequent TEAEs in order of prevalence being dizziness, headache, somnolence, fatigue, and nausea.
New Treatment Option
The results show that eslicarbazepine acetate could provide a new treatment option for newly-diagnosed focal epilepsy patients. Lead author Prof Eugen Trinka, Paracelsus Medical University, Salzburg, Austria, commented: “For this patient population in particular, it is important that the physician takes into consideration individual factors and tailors treatment to the individual. We therefore welcome the news that another treatment has been shown to be effective for these patients, especially one with an easy to use once-daily formulation that has the potential to improve adherence.”
Currently, eslicarbazepine acetate is indicated in adults with newly-diagnosed epilepsy as a monotherapy to treat partial-onset seizures, with or without secondary generalisation in Europe. Additionally, it is indicated as an adjunctive therapy in Europe for partial seizures with or without secondary generalisation in adults, adolescents, and children over 6 years of age.
James Coker, Reporter