Data Suggests Positive Pharmacokinetic Results From Phase I Research of Extended-Release ... (J. Boulware Wesley M. Todd The st...)

Data Suggests Positive Pharmacokinetic Results From Phase I Research of Extended-Release Topiramate

Date:12/6/2010

J. Boulware, Wesley M. Todd

The studies that are the subjects of these posters have been conducted by Upsher-Smith to characterize the pharmacokinetic profile of USL255. The first poster presented data from numerous internally developed topiramate ER formulations. The objective of the research presented was to identify a once daily ER formulation with a lower maximum plasma concentration, a higher trough concentration, and an equivalent extent of exposure as compared to IR topiramate. The PK data from the experimental formulations were compared to IR topiramate, after single doses and/or at simulated steady-state. Results have aided USL researchers in the formulation selection for USL255.

In another study and second poster presentation, the effect of food on the bioavailability of USL255 was assessed. In this phase I, randomized, single-dose, crossover study, 36 healthy subjects received three different treatments (200 mg of USL255 under fasting conditions; 200 mg of USL255 with a high fat meal; or 2 doses of 100 mg IR topiramate dosed 12 hours apart). Based on PK measurements and using standard bioequivalence criteria, the authors determined that the overall extent of absorption of USL255 was not affected by food. However, the presence of food was associated with a delay in the time to maximal plasma concentration of topiramate, a finding that was deemed consistent with the food effect on IR topiramate pharmacokinetics.

In the third poster, data from the same study compared two 100 mg doses of IR topiramate (administered 12 hours apart) and a single 200 mg dose of USL255 for pharmacokinetic equivalence, using standard bioequivalence criteria. The authors reported that administration of 200 mg of USL255 in healthy volunteers provided equivalent topiramate exposure as compared with the 100 mg IR topiramate administered twice daily. USL255 also showed a lower maximum pla
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