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R&D In Brief

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Lacosamide Phase III diabetic neuropathic pain results: UCB's Phase III trial of Vimpat (lacosamide) for treatment of diabetic neuropathic pain met its primary endpoint of sustained reduction in average daily pain scores, firm announces Dec. 11. The randomized, double-blind, placebo-controlled trial in 551 patients showed that the change in the average daily pain was significantly greater with lacosamide 400 mg per day given in standard titration than placebo (p=0.0410). The trial was designed to evaluate lacosamide in two different titration schemes: a standard titration regimen in which patients reached their target dose at day 22, and a fast titration scheme in which the target dose was reached at day eight. The change in pain score with the fast titration regimen was numerically better than placebo, but not statistically significant (p=0.2902). The median time to achieve pain relief was 10 and 11 days for the lacosamide standard and fast titration regimens, respectively, compared with 31 days for placebo. The sodium channel/CRMP-2 agent is under review at FDA with a user fee goal date of July 29, 2008...
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