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Upsher-Smith Presents New Data On The PK Equivalence Of USL255 (Extended-Release Topiramate) When Sprinkled On Food Or Swallowed Intact
Date:12/10/2013

Researchers found that USL255 when sprinkled on soft food or given intact demonstrated PK equivalence for both AUC and Cmax. The findings indicated that USL255 may provide a beneficial option for individuals with difficulty swallowing whole capsules or tablets.

"The positive results of the Phase 1 study demonstrate that USL255 may help address a common issue facing many patients with seizure disorders: challenges swallowing capsules or tablets," said Barry Gidal, Pharm.D., R.Ph., Division Chair, School of Pharmacy, University of Wisconsin. "This specifically designed formulation with the flexibility of once-daily dosing and the option of sprinkle administration may provide added benefits to patients living with the challenge of seizures."

The second presentation evaluated the pharmacokinetic effects of delayed administration of USL255.  Simulations were conducted to assess the effects of taking USL255 6, 12, 18 and 24 hours later than scheduled.  The data demonstrated a return to near steady-state topiramate plasma concentration within one 24-hour dosing interval after the delayed dose was administered. Administration of USL255 up to 18 hours after a missed dose will minimize the duration of decreased topiramate concentrations without significant risk of increased maximal plasma concentrations.

At the AES conference, Upsher-Smith also presented seven abstracts on its recently completed global Phase 3 study, PREVAIL, which enrolled more than 200 patients at 66 centers to evaluate the safety and efficacy of USL255.

Abstracts of the poster presentations can be found online at www.aesnet.org.  To schedule an interview with an investigator, please contact Jessica Orr at jorr@klcpr.com.  


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SOURCE Upsher-Smith Laboratories, Inc.
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