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Upsher-Smith Laboratories Announces Initiation of Phase III Clinical Trial of USL255 (Extended-Release Topiramate) for Adjunctive Treatment of Partial-Onset Epilepsy
Date:6/14/2010

MAPLE GROVE, Minn., June 14 /PRNewswire/ -- Upsher-Smith Laboratories, Inc. today announced the initiation of a global Phase III clinical trial for USL255 (extended-release topiramate), an internally developed program for the management of epilepsy in adults, using the company's proprietary formulation technology.  USL255 is designed to provide convenient once-daily dosing and reduce fluctuations in topiramate blood levels observed with currently available topiramate options.

"The initiation of the Phase III trial for USL255 is a key milestone in Upsher-Smith's vision of becoming a leader in the CNS field," said Alan Rauch, M.D., Chief Medical Officer and Vice President Medical & Regulatory Affairs.  "There is a significant unmet need in the treatment of epilepsy, with as many as 30 percent of patients not adequately controlled using current antiepileptic drugs.  Poor medication compliance may be a contributing factor, and we are excited about the potential for USL255 to offer patients and clinicians a new treatment option with the potential for improved compliance."

The Phase III trial is a randomized, multinational, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of USL255 in patients 18 to 75 years of age with refractory partial-onset seizures with or without secondary generalized seizures.  Further information on this clinical study can be found at http://www.clinicaltrials.gov/ct2/show/NCT01142193?term=upsher&rank=2.

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SOURCE Upsher-Smith Laboratories, Inc.
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