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Upsher-Smith To Present Findings From Global Phase 3 Trial Investigating USL255 (Extended-Release Topiramate) For Adjunctive Treatment Of Epilepsy In Patients With Refractory Partial-Onset Seizures At 2013 American Epilepsy Society Meeting
Date:11/5/2013

MAPLE GROVE, Minn., Nov. 5, 2013 /PRNewswire/ -- Upsher-Smith Laboratories, Inc. (Upsher-Smith), today announced that seven abstracts highlighting results from its Phase 3 (PREVAIL) clinical trial for USL255 (extended-release topiramate) have been accepted for presentation at the American Epilepsy Society's (AES) 67th Annual Meeting in Washington, DC, December 6-10, 2013.

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USL255 is a once-daily, broad-spectrum antiepileptic drug specifically engineered to deliver a smooth pharmacokinetic profile.  It is being developed by Upsher-Smith for the management of epilepsy.  Upsher-Smith's New Drug Application for USL255 has been accepted for review by the U.S. Food and Drug Administration (FDA).

PREVAIL, a global Phase 3 study, enrolled more than 200 patients at 66 centers to evaluate the safety and efficacy of USL255.  USL255 demonstrated a positive treatment effect as adjunctive therapy in patients with refractory partial-onset seizures (POS) compared with placebo and had a statistically significant reduction from baseline in weekly POS frequency during the titration plus maintenance phase compared to placebo (p<0.001). 

"Upsher-Smith is committed to researching and developing potential treatment options for patients living with challenging central nervous system diseases like seizure disorders," said William Pullman, MB BS, BMedSc, PhD, FRACP, Chief Scientific Officer, Upsher-Smith.  "We look forward to sharing the data from our global Phase 3 clinical trial, the first of its kind conducted on an extended-release formulation of topiramate, with the e
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SOURCE Upsher-Smith Laboratories, Inc.
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