Phase III study of USL 255 (Upsher Smith Labs) shows success for Epilepsy treatment

A global Phase III clinical trial for USL 255 (extended-release topiramate), from Upsher Smith Labs, or the management of Epilepsy in adults, has been successfully completed. In the randomized, multicenter, double-blind, placebo-controlled PREVAIL study, USL 255 demonstrated a positive treatment effect as adjunctive therapy in patients with refractory partial-onset seizures (POS) compared with placebo. USL 255 had a statistically significant reduction from baseline in weekly POS frequency during the titration plus maintenance phase compared to placebo (p<0.001).>

The study provides strong evidence suggesting that once-daily USL 255 may be a therapeutic option for patients suffering from partial-onset seizures, according to Steve Chung, Professor of Neurology at the Barrow Neurological Institute, Phoenix and trial investigator. Upsher-Smith's New Drug Application for USL 255 has been accepted for review by the FDA with an anticipated target review date of December 2013. Data will be presented at the 2013 Annual Meeting of the American Epilepsy Society.