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New Lacosamide Data Provides Evidence for Long-Term Efficacy in Diabetic Neuropathic Pain
Date:5/8/2008

in scores increased during placebo treatment and improved to values similar to sub-trial baseline (2.5 on the pain scale) when lacosamide was reintroduced. These findings indicate that, even after 16 months of treatment, lacosamide was still effectively treating pain.

Secondary endpoints indicated a worsening of pain when lacosamide was withdrawn. The intra-individual change in average daily pain score from open-label lacosamide treatment at baseline to the end of the placebo period was statistically significant (p<0.001). More subjects receiving placebo (39%) versus lacosamide (29%) experienced sustained worsening of pain during the withdrawal periods. Similarly, more subjects receiving placebo exited the withdrawal periods early due to increased pain than subjects receiving lacosamide (15% vs. 9%).

The trial revealed no new safety concerns with lacosamide, and there was also no evidence of withdrawal effects following abrupt discontinuation of lacosamide.

About lacosamide

Lacosamide has a dual mode of action and is the first agent of its kind to be clinically studied for the treatment of diabetic neuropathic pain. It selectively enhances slow inactivation of sodium channels and interacts with the neuroplasticity-relevant target -- collapsin-response mediator protein-2 (CRMP-2). Lacosamide is also being investigated for its potential to treat partial onset seizures in adults with epilepsy.

Lacosamide oral tablet has been filed with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) for the treatment of diabetic neuropathic pain. Applications for marketing authorization for lacosamide are supported by data from placebo-controlled clinical trials of more than 1,000 people with diabetic neuropathic pain. In these trials significant and sustained reductions in pain scores were seen versus placebo. The most common adverse events of lacosamide (greater than or equal to 10%) reported in these trials incl
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