Belgium’s UCB says that it has filed lacosamide with US regulators as a treatment for epilepsy and diabetic neuropathic pain.
The Brussels-headquartered firm notes that the US Food and Drug Administration has accepted for filing its New Drug Application for the use of a tablet formulation of lacosamide in the treatment of diabetic neuropathic pain, to be called Vimpat. The drug has also been filed as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy in three formulations – tablets, syrup and an intravenous injection.
UCB noted that in clinical trials of over 800 people with diabetic neuropathic pain, “significant and sustained reductions” in pain scores were seen versus placebo, while the epilepsy NDA is supported by data from three trials of 1,300 adults with uncontrolled partial onset seizures, despite taking one to three antiepileptic drugs. In these studies, significantly greater 50% responder rates and reductions in median seizure frequency were demonstrated versus placebo, the firm adds.
An application for marketing authorisation of Vimpat was made by UCB’s subsidiary Schwarz Pharma to the European Medicines Agency in August. Approvals would prove to be a welcome boost for UCB as it is facing the loss of patent protection on key products such as the antihistamine Zyrtec (cetirizine) and the blockbuster antiepileptic Keppra (levetiracetam).
