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Upsher-Smith Successfully Completes Phase III Study Of USL255 (Extended-Release Topiramate) For Adjunctive Treatment Of Epilepsy In Patients With Refractory Partial-Onset Seizures
Date:5/22/2013

uggesting that once-daily USL255 may be a therapeutic option for patients suffering from partial-onset seizures."

"The successful completion of the Phase III clinical trial of USL255 marks an exciting milestone in Upsher-Smith's focused strategy to develop and deliver therapies to address central nervous system disorders," said Mark Evenstad , President and CEO of Upsher-Smith.  "Underpinning this strategy is our commitment to advancing pharmacotherapy to improve lives."

About the Trial
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.  PREVAIL was conducted under a Special Protocol Assessment (SPA) agreement with the FDA.  More information about the trial is available at www.clinicaltrials.gov (NCT01142193). 

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.  The open-label extension study can be found by searching NCT01191086 on www.clinicaltrials.gov.

About Epilepsy
Epilepsy is a medical condition that causes seizures affecting a variety of cognitive and physical functions.  More than two million people in the U.S. are estimated to be affected by epilepsy with about 200,000 new cases of epilepsy diagnosed each year.1 For many people with epilepsy, medication will prevent seizures if taken regularly, but some people continue to have seizures.1  As many as two out of three patients treated for epilepsy ha
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SOURCE Upsher-Smith Laboratories, Inc.
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