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Data Suggests Positive Pharmacokinetic Results From Phase I Research of Extended-Release Topiramate
Date:12/6/2010

MAPLE GROVE, Minn., Dec. 6, 2010 /PRNewswire/ -- Data presented yesterday showed that USL255, a novel extended-release (ER) formulation of topiramate, was associated with less fluctuation in topiramate plasma levels than immediate-release (IR) topiramate in healthy volunteers.  

These and other findings from the USL255 early development program were presented Sunday, Dec. 5, at the 64th annual American Epilepsy Society (AES) meeting in San Antonio, TX.  USL255, developed by Upsher-Smith Laboratories, Inc. and now the subject of a global Phase III clinical study, is designed to provide convenient once-daily dosing with smoother topiramate plasma levels than traditional IR dosage forms.  

"Fluctuation in plasma levels of certain antiepileptic drugs is thought to have the potential to contribute to increased side effects for patients with epilepsy during peak concentrations or to "break-through" seizures at trough concentrations just prior to the next dose.  Therefore, a topiramate formulation that could offer reduced fluctuation in plasma levels is of interest to many clinicians," said Mark Halvorsen, Pharm.D., Senior Director, Clinical Development.  

Abstracts of the poster presentations can be found online at www.aesnet.org. Titles and authors are:

  • "Development and Optimization of Extended-Release Formulations of Topiramate." Authors: Lawrence J. Lambrecht, Mark B. Halvorsen, Michael J. Boulware, Wesley M. Todd, John A. Carrithers
  • "The Effect of Food on the Bioavailability of USL255, A Novel Extended-Release Formulation of Topiramate." Authors: Wesley M. Todd, Lawrence J. Lambrecht, Michael J. Boulware, Mark B. Halvorsen
  • "Pharmacokinetic Equivalence Between Immediate-Release Topiramate and USL255, a Novel Extended-Release Formulation of Topiramate." Authors: Mark B. Halvorsen, Lawrence J. Lambrecht, Michael
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SOURCE Upsher-Smith
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