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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 epilepsy community at this year's AES meeting."

About Upsher-Smith's Phase 3 (PREVAIL) Clinical Trial
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 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.

Upsher-Smith's Epilepsy Pipeline
Upsher-Smith's clinical development pipeline includes three investigational drugs that are being studied for the management of seizure disorders.  USL255 is an investigational once-daily, extended-release topiramate for the management of epilepsy.  The pipeline also includes USL261, an investigational intranasal midazolam for the rescue treatment of seizures in patients who require control of intermittent bouts of increased seizure activity, often called seizure clusters, which is the subject of an ongoing international Phase 3 clinical trial (ARTEMIS1) with an open-label safety extension study.  In addition, USL260 (tonabersat) is in early clinical development as a potential first-in-class neuronal gap junction modulator.

About Upsher-Smith
Upsher-Smith, founded in 1919, is an independent and privately-owned specialty pharmaceutical company headquartered in Maple Grove, Minnesota that focuses on product growth and innovation for branded and generic pharmaceuticals.  Upsher-Smith has a particular focus on developing therapies to assist people suffering from central nervous system diseases and also markets products relating to cardiology, dermatology, and women's health.  For more information, visit www.upsher-smith.com.


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