New study of USL 255 published in Epilepsia

A new study shows that USL 255 (extended-release topiramate), from Upsher Smith Labs, demonstrated equivalent systemic exposure with an improved topiramate (TPM) pharmacokinetic profile at steady-state, as measured by a significantly lower Cmax and higher Cmin, when compared to immediate-release topiramate (TPM-IR) in patients with Epilepsy. Additionally, upon switching from TPM-IR, USL 255 maintained steady state topiramate concentrations.

Although both study drugs were generally well tolerated in the healthy volunteers, subjects receiving 200 mg/day of USL 255 were observed to have fewer side effects related to cognition and memory impairment than those receiving TPM-IR. According to researchers, the results suggest that USL 255's improved PK profile, reduced fluctuations in topiramate steady-state plasma concentrations and tolerability may offer patients a once-daily alternative to twice-daily commercially available immediate-release topiramate. The study was published in the August issue of Epilepsia: "Comparative steady-state pharmacokinetic evaluation of immediate-release topiramate and USL255, a once-daily extended-release topiramate formulation." Meir Bialer et al. Epilepsia, 20 May 2013, pages 1444�1452 DOI: 10.1111/epi.12225