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Data Presented at AAN Support Potential for Adjunctive use of Intravenous Lacosamide as Short-Term Replacement for Oral Treatment in Partial Epilepsy
Date:4/18/2008

SMYRNA, Ga., April 18 /PRNewswire/ -- Data presented today at a platform session of the 60th Annual Meeting of the American Academy of Neurology (AAN) in Chicago support the potential for adjunctive use of intravenous lacosamide 200-600 mg/day using infusion durations as fast as 10 minutes for short term replacement of oral lacosamide in adult patients with partial onset seizures.

Regulatory filings for lacosamide oral tablet, oral syrup and intravenous formulation are currently under review by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) for use as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy.

"When patients are temporarily hospitalized or undergo surgical procedures making it difficult to swallow, they may not be able to take their oral antiepileptic drug. In these circumstances, and in order to maintain seizure control, a short-term, alternative administration of their antiepileptic medication is desirable," said Gregory Krauss, MD, Department of Neurology, Johns Hopkins Epilepsy Center, Baltimore. "In this study, short-term intravenous therapy with lacosamide was well tolerated when substituted for oral lacosamide treatment in patients with certain epilepsy types."

The study was a multi-center, multi-national, open-label trial of 160 patients who were receiving oral lacosamide for at least eight weeks. For the last two weeks of the trial, these patients were on a stable twice daily dosing regimen of lacosamide (200-800 mg/day), as well as concomitant antiepileptic drugs with or without vagus nerve stimulation. During the treatment period (two to five days), oral lacosamide was replaced with intravenous lacosamide, infused at a rate of 10, 15 and 30 minutes.

Intravenous lacosamide was generally well-tolerated and the frequency of adverse events did not increase with more days of exposure or shorter infusion durations. The incidence of adverse events
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