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Upsher-Smith Research Shows Unique Pharmacokinetic Profile of USL255 Extended Release Topiramate
Date:4/26/2012

s:  Tricia L. Braun, Lawrence J. Lambrecht, Wesley Mark Todd, Mark B. Halvorsen
  • "Switching between Immediate- and Extended-Release Formulations Does Not Affect the Steady-State Pharmacokinetic Profile of Topiramate"  Poster # P06.112.  Authors:  Lawrence J. Lambrecht, Tricia L. Braun, Wesley Mark Todd, Mark B. Halvorsen
  • Extended-Release Topiramate (USL255) Exhibits Linear Dose-Proportional Pharmacokinetic Characteristics"  Poster # P06.128.  Authors:  Mark B. Halvorsen, Lawrence J. Lambrecht, Wesley Mark Todd
  • About The Studies

    The studies, that are the subject of these posters, have been conducted by Upsher-Smith to characterize the pharmacokinetic profile of USL255.  The first poster compared the steady-state PK profile of once-daily USL255 to the twice-daily IR formulation.  In this Phase I, open-label, 2-way crossover study, healthy subjects were up-titrated to 200 mg of topiramate (either USL255 or twice daily IR topiramate) over 12 days and maintained on 200 mg for 14 days.  On day 15, subjects were crossed over, without washout, to the other topiramate formulation through day 28.  Subjects were then down-titrated off the study drug over eight days.  The study results confirmed that USL255 administered once-daily provided an improved PK profile as determined by an equivalent AUC, lower Cmax, higher Cmin and a reduced fluctuation index at steady-state when compared to twice-daily IR topiramate. All treatment-emergent adverse events were mild in severity.

    An additional analysis of this Phase I data, and second poster, evaluated tolerability and maintenance of steady-state plasma concentrations during a formulation switch from IR topiramate to USL255.  Healthy volunteers were randomized into two groups receiving either 200 mg of USL255 once-daily or 100 mg of IR topiramate twice-daily through Period One (days 1-14).  On day
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    SOURCE Upsher-Smith Laboratories, Inc.
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