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PK Study Comparing Upsher-Smith's Extended-Release Topiramate Formulation (USL255) With Topamax® Published Online In Epilepsia
Date:7/25/2011

MAPLE GROVE, Minn., July 25, 2011 /PRNewswire/ -- In a comparative pharmacokinetic (PK) study, Upsher-Smith Laboratories' USL255, a new, once-daily extended-release formulation of topiramate in development for the management of epilepsy in adults, was shown to be bioequivalent to twice-daily immediate-release topiramate (Topamax®*) in its extent of absorption.  Furthermore, USL255, administered with or without food, demonstrated a slower absorption profile compared with Topamax®.  The more consistent plasma profile of USL255 allows for once-daily dosing with diminished fluctuations in topiramate plasma levels.  The results of this study were published in the online edition of Epilepsia on July 20, 2011.

"In the study, this new topiramate extended-release formulation demonstrated less fluctuation between the peak and trough concentrations than immediate-release topiramate; thereby providing a relatively flat topiramate plasma concentration versus time profile that should allow for once-daily dosing.  Once-daily dosing may simplify topiramate therapy in adult epilepsy patients," said Larry Lambrecht, Pharm.D., first author.  "In theory, reducing fluctuations of plasma concentrations of antiepileptic drugs may also minimize potential concentration-related adverse events."

About the PK StudyThe randomized, open-label, cross-over study had three dosing periods separated by 21 days of washout between treatments. Thirty-six healthy adult volunteers received single doses of USL255 (200 mg) in fasted and fed conditions and two doses of Topamax® (100 mg) administered 12 hours apart. Topiramate plasma samples were analyzed by liquid chromatography with tandem-mass spectroscopy.  

A single dose of USL255 was found to be bioequivalent to Topamax® in its extent of absorption; however, it had a slower extent of absorption as reflected by its later t(max) (time to reach peak plasma con
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