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Upsher-Smith Debuts Positive Results From Global Phase 3 Study Evaluating USL255 (extended-release topiramate) In Epilepsy Patients With Refractory Partial-Onset Seizures
Date:12/9/2013

MAPLE GROVE, Minn., Dec. 9, 2013 /PRNewswire/ -- Upsher-Smith Laboratories, Inc. (Upsher-Smith) today presented results from its global Phase 3 (PREVAIL) study of USL255 (extended-release topiramate), showing that the investigational drug met its primary and secondary endpoints for efficacy and demonstrated favorable safety and tolerability in epilepsy patients with refractory partial-onset seizures (POS). The data were presented for the first time 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 (PK) profile. Upsher-Smith's New Drug Application for USL255 has been accepted for review by the U.S. Food and Drug Administration (FDA).

Findings presented at the meeting showed that USL255 was associated with a significantly greater median percent reduction in weekly POS frequency compared with placebo (39.5% vs 21.6%, P<0.001) after 11 weeks of treatment. The majority of treatment-emergent adverse events (TEAEs) reported were mild to moderate in intensity and generally resolved over time.  Individual neurocognitive adverse events were each observed at incidence rates of 2.4 percent or less in patients taking USL255.  Although ongoing, to-date 96.8 percent of patients who completed the double-blind portion of PREVAIL elected to continue in a year-long, open-label extension study of USL255.

"Topiramate is a well-known, effective agent for the treatment of a variety of seizure disorders, but many patients experience challenging cognitive side effects whil
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SOURCE Upsher-Smith Laboratories, Inc.
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3. 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
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