Upsher-Smith announced the completion of its global Phase 3 clinical trial for USL255 (extended-release topiramate), for the management of epilepsy in adults, using the company’s proprietary formulation technology. Upsher-Smith’s New Drug Application for USL255 has also been accepted for review by the FDA. USL255 is engineered to provide once-daily dosing and reduce fluctuations in topiramate blood levels.
The PREVAIL trial was a randomized, multicenter, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of USL255 as adjunctive therapy in patients with refractory partial-onset seizures. An open-label extension study evaluating the safety of USL255 as adjunctive therapy in patients with refractory partial-onset seizures who had previously participated in PREVAIL is ongoing.
In the study, USL255 demonstrated a positive treatment effect as adjunctive therapy in patients with refractory partial-onset seizures compared to placebo. USL255 had a statistically significant reduction from baseline in weekly partial-onset seizure frequency during the titration plus maintenance phase compared to placebo (P<0.001).
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