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Extended-Release Topiramate Shows Promise in Late-Stage Epilepsy Trial
Treatment reduces frequency of partial-onset seizures (December 9)
Positive results have been reported from a global phase III study of extended-release topiramate (USL255, Upsher-Smith Laboratories). The investigational drug met its primary and secondary endpoints for efficacy and demonstrated favorable safety and tolerability in epilepsy patients with refractory partial-onset seizures (POS).
The new data were presented at the 67th Annual Meeting of the American Epilepsy Society, held Dec. 6–10 in Washington, D.C.
The PREVAIL trial was a randomized, multicenter, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of extended-release topiramate as adjunctive therapy in 249 epilepsy patients with refractory POS.
The findings presented at the meeting showed that topiramate was associated with a significantly greater median percent reduction in the weekly frequency of POS compared with placebo (39.5% vs. 21.6%, respectively; P < 0.001) after 11 weeks of treatment. Individual neurocognitive adverse events were observed at incidence rates of 2.4% or less in patients treated with topiramate. Although the PREVAIL trial is ongoing, 96.8% of patients who completed the double-blind portion of the study elected to continue in a year-long, open-label extension study.
Topiramate is a once-daily, broad-spectrum antiepileptic drug. A New Drug Application (NDA) for extended-release topiramate has been accepted by the FDA.
Source: Upsher-Smith Laboratories; December 9, 2013.