POSITIVE DATA ANNOUNCED FROM PHASE III LACOSAMIDE STUDY

Germany-based Schwarz Pharma has announced the first headline data from its Phase III program with the active compound lacosamide for diabetic neuropathic pain. Lacosamide significantly reduced diabetic neuropathic pain and showed a consistent safety profile compared to previous trials with lacosamide for the target dose of 400 mg/day.

The overall frequency of adverse events for lacosamide 400 mg/day was on the same level as placebo.

In the double-blind, placebo-controlled multicenter trial, conducted in the U.S., lacosamide showed statistical significance with 400 mg/day for the primary efficacy variable (change in pain from baseline to end of treatment). Differences between placebo and lacosamide were statistically significant when compared over the entire titration period, the twelve-week maintenance period, and the overall treatment period.