Drug Pipeline Series: Phase III, Oct 31 - Nov 6, 2006

SCHWARZ REPORTS POSITIVE RESULTS FROM EPILEPSY TRIAL
Schwarz Pharma has announced that results from the second Phase III trial with oral lacosamide for adjunctive therapy of epilepsy are clinically relevant and statistically significant in both primary variables, reduction of seizure frequency and a 50 percent responder rate.
This multicenter, double-blind, placebo-controlled clinical trial, performed in the United States, included a titration phase of six weeks and a maintenance phase of 12 weeks. A total of 405 patients with uncontrolled partial seizures were randomized to treatment with adjunctive placebo or 400- or 600-mg lacosamide divided into two doses per day. The primary variables were reduction of seizure frequency and a 50 percent response to treatment.
Both the 400- and 600-mg/day lacosamide treatment groups were statistically significantly over placebo in reducing seizure frequency from baseline to maintenance. Statistical significance was also observed for both lacosamide doses in the statistical analysis of responders. Lacosamide demonstrated an adverse events profile generally expected with CNS drugs.