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Upsher-Smith Presents Data Supporting Favorable Tolerability And Consistent Pharmacokinetic Profile Of Once-Daily USL255 (Extended-Release Topiramate)
Date:3/20/2013

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  • Single, High Doses of USL255, an Extended-Release Topiramate Formulation, are Well Tolerated and Demonstrate a Dose-Proportional Pharmacokinetic Profile in Healthy Subjects 
    P04.212. Session P04:  Epilepsy:  Antiepileptic Medications:  Special Populations and Pharmacokinetics
  • USL255 (Extended-Release Topiramate) Data

    The objective of the single-dose, Phase I study was to determine the maximum tolerated dose (MTD), safety/tolerability, and pharmacokinetics (PK) of ascending doses of USL255 in healthy volunteers.  The study planned for sixty subjects to be randomized (4:1) to USL255 (600, 800, 1000, 1200, 1400 or 1600 mg) versus placebo.  PK samples were drawn, and tolerability and vital signs assessed, out to 14 days post-dose.  Escalation to the next dose level was done only after USL255 demonstrated suitable tolerability four days post-dose, assessed by a priori tolerability criteria.  Dose proportionality and linearity of topiramate exposure was determined using statistical models.  The study results showed single-ascending doses of USL255 were generally well tolerated from 600 – 1200 mg, with 1200 mg established as the MTD.  AUC and Cmax were dose proportional and linear over the entire 600 – 1400 mg dose range.

    USL255 is an investigational treatment being developed for the management of epilepsy in adults and is also the subject of a global Phase III clinical trial (PREVAIL).  Information about the trial can be found at http://www.clinicaltrials.gov (NCT01142193).

    Upsher-Smith's Epilepsy Pipeline

    Upsher-Smith's clinical development pipeline includes three investigational drugs that are being studied for the management of epilepsy.  USL255 is an i
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    SOURCE Upsher-Smith Laboratories, Inc.
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