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Upsher-Smith Presents New Data On The PK Equivalence Of USL255 (Extended-Release Topiramate) When Sprinkled On Food Or Swallowed Intact
Date:12/10/2013

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 focu
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SOURCE Upsher-Smith Laboratories, Inc.
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3. Upsher-Smith To Present New Research On USL255 (Extended-Release Topiramate) At 2013 American Epilepsy Society Annual Meeting
4. 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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