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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