Data Presented at AAN Support Potential for Adjunctive use of Intravenous Lacosamide as Short-Term Replacement for Oral Treatment in Partial Epilepsy

SMYRNA, Ga., April 18, 2008 /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 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 data from three clinical trials with a total of approximately 1,300 adults with uncontrolled partial onset seizures, despite taking one to three AEDs. In these studies, significantly greater 50% responder rates and reductions in median seizure frequency were seen versus placebo. The most common adverse events of lacosamide (greater than or equal to 10% and greater than placebo) reported in these trials included dizziness, headache, nausea and diplopia.

Posted: April 2008

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