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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

UCB announces clinical data presented at the 60th Annual Meeting of the

American Academy of Neurology (AAN) in Chicago

SMYRNA, Ga., April 16 /PRNewswire/ -- UCB presented efficacy and safety results from pooled analyses of Phase II and III double-blind, randomized, placebo-controlled clinical trials investigating lacosamide for the treatment of diabetic neuropathic pain. These data, which were presented at the 60th Annual Meeting of the American Academy of Neurology (AAN) in Chicago, showed that lacosamide significantly reduced pain in patients with diabetic neuropathic pain and was generally well-tolerated.

Lacosamide is currently under review with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) for the treatment of diabetic neuropathic pain and as adjunctive therapy for the treatment of partial onset seizures in adults with epilepsy.

"Neuropathy can be a painful and potentially debilitating complication of diabetes, and there is still a need for new treatment options," said Aziz Shaibani, M.D., F.A.C.P., lacosamide clinical investigator and director of the Nerve and Muscle Center of Texas in Houston. "These data showed that lacosamide reduced pain in patients with diabetic neuropathic pain and was generally well-tolerated."

Pooled Efficacy Analysis

Primary efficacy was evaluated among patients treated with 400 mg/day of lacosamide by examining the change in average daily pain score, from baseline to the last four weeks of maintenance in three Phase III, fixed-dose trials (SP742, SP743, SP768) and from baseline through the entire maintenance period in one Phase II, flexible-dose trial (SP614). The pain score was based on an 11-point Likert Scale ranging from zero (no pain) to 10 (worst possible pain).

The mean reduction in pain score reached the level of statistical significance in SP614, SP742 and SP768 (p=0.039, 0.01 and 0.0507, respectively). Significance was not
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SOURCE UCB
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