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Upsher-Smith Laboratories Announces Initiation of Open-Label Extension Study of USL255 (Extended-Release Topiramate) for Adjunctive Treatment of Partial-Onset Epilepsy
Date:11/9/2010

MAPLE GROVE, Minn., Nov. 9, 2010 /PRNewswire/ -- Upsher-Smith Laboratories, Inc. today announced the addition of an open-label extension study to PREVAIL, its global Phase III clinical trial for USL255 (extended-release topiramate). An internally developed program for the adjunctive treatment of adult epilepsy patients with partial-onset seizures, USL255 is designed to provide convenient once-daily dosing and reduce fluctuations in topiramate blood levels observed with currently available topiramate options.

"The open-label extension study will provide additional long term tolerability information regarding USL255 as adjunctive therapy in patients with refractory partial-onset seizures who completed the Phase III study and choose to participate in the extension study," said Alan Rauch, M.D., Chief Medical Officer and Vice President Medical & Regulatory Affairs. "We are pleased to offer these patients the opportunity to continue on or switch to USL255 at the conclusion of the Phase III clinical trial."

PREVAIL, the Phase III study, is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). The PREVAIL study is entitled "Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-GRoup, Phase III Study to EVAluate the Efficacy and Safety of USL255 as Adjunctive Therapy In Patients with Refractory PartiaL-Onset Seizures."

About the Open-Label Extension Study

All patients completing the PREVAIL Phase III study will be eligible to enroll in the extension study, which continues to examine individuals aged 18 to 75 years with refractory partial-onset seizures with or without secondary generalized seizures. Laboratory evaluations, vital signs and physical examinations will be conducted at regular intervals to support patient safety.

Further information on this clinical study can be found
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SOURCE Upsher-Smith Laboratories, Inc.
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