Schwarz Pharma submit EMEA application for epilepsy drug

Schwarz Pharma has announced that it has submitted an application for marketing approval with the European Medicines Agency (EMEA) for lacosamide as an adjunctive therapy for epilepsy.

This submission has been accepted, while the company is also planning a submission with European regulators later in the year for the same compound as a treatment for diabetic neuropathic pain.

Lacosamide is a primarily an orally-administered compound, though it has also had an intravenous formulation submitted to the EMEA. It is an anticonvulsant with an innovative dual mode of action to reduce seizures in patients that have failed treatment with a number of traditional and modern antiepileptics.

Iris Loew-Friedrich, chief science officer at Schwarz Pharma, said: “Adjunctive treatment with lacosamide significantly reduced seizure frequency in patients with uncontrolled seizures during our clinical trial program.”

She added that the submission for marketing approval occurring in the second quarter of 2007 was in line with its earlier forecasts, while the firm aimed to submit an application with the US Food and Drug Administration later in the year.

In February 2007, Schwarz Pharma announced positive preliminary results of a withdrawal-designed phase III study investigating lacosamide as a treatment for diabetic neuropathy patients.