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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

Saturday, April 19, 2008 General News J E 4
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SMYRNA, Ga., April 18 Data presented today at a platformsession of the 60th Annual Meeting of the American Academy of Neurology (AAN)in Chicago support the potential for adjunctive use of intravenous lacosamide200-600 mg/day using infusion durations as fast as 10 minutes for short termreplacement of oral lacosamide in adult patients with partial onset seizures.

Regulatory filings for lacosamide oral tablet, oral syrup and intravenousformulation are currently under review by the U.S. Food and DrugAdministration (FDA) and the European Medicines Agency (EMEA) for use asadjunctive therapy in the treatment of partial onset seizures in adults withepilepsy.

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

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

Intravenous lacosamide was generally well-tolerated and the frequency ofadverse events did not increase with more days of exposure or shorter infusiondurations. The incidence of adverse events was comparable across all infusiondurations (10-, 15- and 30-minute infusions), with headache (5%, 7%, 8%) anddizziness (5%, 6%, 8%) being the most commonly reported. Plasma concentrationswere proportional to the actual daily dose given and similar across allinfusion duration groups. Intravenous lacosamide was also locallywell-tolerated with no serious infusion site reactions. In this study,intravenous lacosamide was administered directly via injection, with nodiluent required.

These results support data from an earlier multi-center, double-blind,randomized, inpatient trial that evaluated intravenous lacosamide (200-600mg/day) as replacement for oral lacosamide in patients with partial onsetseizures. In that double-blind trial, intravenous lacosamide showed a similarprofile to oral lacosamide when administered as 30- or 60-minute twice dailyinfusions. The data presented at AAN demonstrated that intravenous lacosamidewas also generally well-tolerated at shorter infusion durations.

Intravenous lacosamide was developed as an alternative for patients whotemporarily cannot receive oral therapy. Doses of intravenous lacosamide areequivalent to the oral form of the drug and do not require conversion.

About lacosamide: Lacosamide has a dual mode of action and is the firstagent of its kind to be clinically studied for the treatment of epilepsy. Itselectively enhances slow inactivation of sodium channels and interacts withthe neuroplasticity-relevant target-collapsin-response mediator protein-2(CRMP-2). Lacosamide is also being investigated for its potential effect inreducing diabetic neuropathic pain.

Lacosamide-oral tablet, oral syrup and intravenous formulation-has beenfiled with the U.S. FDA and the EMEA for use as adjunctive therapy in thetreatment of partial onset seizures in adults with epilepsy and is currentlyunder review.

Applications for marketing authorization for lacosamide in epilepsy aresupported
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