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Data Presented at AAN Show That Lacosamide Significantly Reduced Pain and was Generally Well Tolerated in Patients With Diabetic Neuropathic Pain
Date:4/16/2008

reached for the primary endpoint in SP743, likely due to a strong placebo effect at the final visit.

Additionally, a meta-analysis of all Phase III, fixed-dose trials showed a significant mean reduction in pain score of -2.14 for the lacosamide group compared with -1.57 for placebo (p=0.0006). Results on the secondary outcome of pain reduction from baseline through the entire maintenance period were also statistically significant for all fixed-dose trials (p=<.001).

Pooled Safety Analysis

In these trials, the overall percentage of patients who discontinued treatment due to adverse events was similar between the placebo group and the lacosamide 200 and 400 mg/day groups (24.7 percent, 29.9 percent and 32.9 percent, respectively). The percentage was higher (55.4 percent) in the group receiving 600 mg/day of lacosamide.

Overall, treatment emergent adverse events (TEAEs) were reported by a similar percentage of patients in the placebo (72.9 percent) and in the pooled lacosamide groups (76.3 percent). The most frequently reported TEAEs in the pooled lacosamide group, which were greater than placebo, were dizziness (16.3 vs. 5.2 percent), nausea (10.3 vs. 6.2 percent), fatigue (6.7 vs. 4.1 percent) and tremor (6.5 vs. 1.0 percent). In addition, lacosamide had no effect on body weight in these trials.

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 collapsin-response mediator protein-2 (CRMP-2). Lacosamide is also being investigated for its potential as adjunctive therapy 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 au
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