Sepracor reports encouraging results from Phase III epilepsy trial

The three large-scale, randomized, double-blind, placebo-controlled, multi-center, add-on Phase III trials in partial epilepsy included an aggregate of 1,049 patients 18 years of age or older from 23 countries. Patients were randomized to eslicarbazepine acetate or placebo and then were followed up in an open-label study for one year.

In the intent-to-treat population, there was a 35.4% relative reduction in seizure frequency over the 12-week period for the 800mg once-daily dosage regimen (p=0.0002) and a 38.8% reduction for the 1200mg once-daily dosage regimen (p=0.0001) compared with placebo.

Furthermore, 36.3% of patients receiving 800mg daily and 43.5% of patients receiving 1200mg daily experienced a 50% or greater reduction in seizure frequency over the 12-week maintenance period (p=0.0001 and p<0.0001, respectively). Reduction in seizure frequency and responder rates were sustained over the 52-week treatment period. Patients administered eslicarbazepine acetate also demonstrated statistically significant improvements in mean quality of life as measured by quality of life in epilepsy inventory-31 scores at week 52 compared with baseline measures. Eslicarbazepine acetate was also generally well tolerated.