The application includes three lacosamide formulations, tablets, syrup and an intravenous injection. The proposed trade name for lacosamide is Vimpat.
The new drug application (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.
Iris Loew-Friedrich, global head of development at UCB, said: “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.”