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

15, volunteers were immediately switched to the alternate formulation for Period Two (days 15-28), without washout.  Pharmacokinetic profiles were determined through blood samples taken at steady-state (days 14 and 28) and at switch (day 15).  Steady-state was considered maintained if slope estimates for minimum concentrations (Cmin) were not significantly different from zero.  Tolerability of USL255 and IR topiramate were evaluated through adverse events monitoring, vital sign measurements, and clinical laboratory evaluations.  The results for both formulations were similar at steady-state and around the switch in formulation.  Additionally, no significant differences in slope estimates were identified during conversion, suggesting that switching formulations did not affect maintenance of steady-state plasma concentrations.

The final poster 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 sev
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