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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

was comparable across all infusion durations (10-, 15- and 30-minute infusions), with headache (5%, 7%, 8%) and dizziness (5%, 6%, 8%) being the most commonly reported. Plasma concentrations were proportional to the actual daily dose given and similar across all infusion duration groups. Intravenous lacosamide was also locally well-tolerated with no serious infusion site reactions. In this study, intravenous lacosamide was administered directly via injection, with no diluent required.

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

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

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 epilepsy. 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 effect in reducing diabetic neuropathic pain.

Lacosamide-oral tablet, oral syrup and intravenous formulation-has been filed with the U.S. FDA and the EMEA for use as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy and is currently under review.

Applications for marketing authorization for lacosamide in epilepsy are supported by da
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