MAPLE GROVE, Minn., April 11, 2011 /PRNewswire/ — Upsher-Smith
Laboratories today announced the presentation of data indicating
that once daily administration of USL255, a proprietary
extended-release (ER) formulation of the epilepsy medication
topiramate, was associated with less fluctuation in topiramate
plasma levels compared to immediate-release (IR) topiramate
administered twice daily in healthy volunteers.
These data were presented Monday, April 11 at the American
Academy of Neurology’s (AAN) 2011 Annual Meeting in Honolulu, HI,
and marked another milestone in Upsher-Smith’s commitment to
addressing unmet patient needs in epilepsy and other central
nervous system diseases.
USL255 is being developed for the treatment of adults with
partial-onset seizures and is the subject of a Phase III clinical
trial (PREVAIL). This proprietary extended-release formulation is
designed to provide convenient once-daily dosing with reduced
fluctuation in topiramate plasma levels versus traditional IR
dosage forms.
“Fluctuations in plasma levels with certain antiepileptic drugs
have the potential to cause challenges for patients with epilepsy.
There is concern that some individuals may experience increased
side effects during peak concentrations, or suffer break-through
seizures if plasma levels fall too low. We are excited to share
this Phase I data about USL255 and its encouraging pharmacokinetic
profile with clinicians at AAN,” said Mark Halvorsen, Pharm.D.,
Senior Director, Clinical Development at Upsher-Smith.
Abstracts of the poster presentations can be found online at www.aan.com. Titles and authors
are:
- “Development and Optimization of Extended-Release Formulations
of Topiramate.” Authors: Lawrence J. Lambrecht, Wesley M. Todd,
John A. Carrithers, Mark B. Halvorsen. - “Pharmacokinetic Equivalence Between Immediate-Release
Topiramate and USL255 (A Novel‘/>”/>
