UCB Announces FDA Filing for lacosamide in the Treatment of Partial Onset Seizures in Adults wit...( U.S. Food and Drug Administration (...),Health

U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for the use of lacosamide as adjunctive therapy in

the treatment of partial onset seizures in adults with epilepsy.

ATLANTA, Nov. 29 /PRNewswire/ -- UCB announced today that the U.S. Food and Drug Administration has accepted for filing the New Drug Application (NDA) for the use of lacosamide as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. The application includes three lacosamide formulations -- tablets, syrup and an intravenous injection. The proposed trade name for lacosamide is Vimpat(TM).

"This filing is another step in support of UCB's epilepsy franchise and its long-term commitment to advancing treatment options for patients with epilepsy," said Iris Loew-Friedrich, MD, PhD, Global Head of Development, UCB.

The NDA for lacosamide in epilepsy is 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 antiepileptic drugs (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%) reported in these trials included dizziness, headache, nausea and diplopia.

A similar filing made to the European Medicines Agency (EMEA) earlier this year for the use of lacosamide as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy, was accepted and is currently under review.

About Epilepsy: Epilepsy is a chronic neurological disorder affecting 40 million people worldwide including 2.5 million people in the US. It is caused by abnormal, excessive electrical discharges of the nerve cells or neurons in the brain. Epilepsy is characterized by a tendency to have recurrent seizures and defined by two or more unprovoked s
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