Positive Phase III Results for Extended-Release Topiramate in Epilepsy Patients
FDA review expected in December (May 22)
Positive results have been reported from a global phase III study of extended-release topiramate (USL255; Upsher-Smith Laboratories) in adults with epilepsy. A new drug application (NDA) for the compound has been accepted for review by the FDA, with an anticipated target review date of December 2013.
In the new study, USL255 demonstrated a positive treatment effect as adjunctive therapy in patients with refractory partial-onset seizures (POS) compared with placebo. The drug achieved a statistically significant reduction from baseline in the weekly frequency of POS during the titration-plus-maintenance phase compared with placebo (P < 0.001).
Preliminary findings from this study will be presented at the 2013 Annual Meeting of the American Epilepsy Society, to be held Dec. 6–10 in Washington, D.C.
The phase III 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 POS.
An open-label extension study to evaluate the safety of USL255 as adjunctive therapy in patients with refractory POS who had participated in PREVAIL is ongoing.
Source: Upsher-Smith Laboratories; May 22, 2013.