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Upsher-Smith Presents Updated Extended-Release Topiramate Data (USL255) at AES Meeting
Date:12/5/2011

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About The Studies

The first study assessed dose-proportionality, linearity and tolerability of USL255.  In this Phase I, single-dose, open-label, 5-way crossover study, 30 healthy subjects were randomized into one of five treatment sequences with six subjects per sequence.  Subjects were given each dose of USL255 (25, 50, 100, 200 and 400 mg) in varying order depending on their assigned treatment sequence.  Following each treatment, subjects entered a three week washout period with blood samples being collected throughout the first 14 days.  The investigators concluded that USL255's topiramate exposure was linear and dose-proportional from 25 mg up to 400 mg.  Subsequent analyses compared dose-normalized Cmax values of USL255 400 mg to 200 mg, and 200 mg to 100 mg.  All 90% confidence intervals were between 0.80 – 1.25 which indicates that Cmax changed dose-proportionally within double dose increases between 100 mg and 400 mg.  As expected, the number of subjects who experienced a treatment-emergent adverse event generally increased with ascending doses, and all were mild to moderate in severity.

The second study 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 wer
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SOURCE Upsher-Smith Laboratories, Inc.
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