Topline Results Back Lacosamide as Epilepsy Monotherapy

Susan Jeffrey

March 11, 2013

Topline results of a phase 3 trial support a supplemental New Drug Application for lacosamide (Vimpat, UCB) as monotherapy for patients with partial-onset seizures, the company has announced.

Lacosamide is currently approved by the US Food and Drug Administration and the European Medicines Agency only as adjunctive therapy in patients with partial-onset seizures with or without secondary generalization (age 17 years or older in the United States and 16 years or older in the European Union).

This phase 3 trial aimed to evaluate the efficacy and safety of conversion to lacosamide monotherapy among patients already treated with other therapies, compared with an historical control.

"The study met its primary endpoint, demonstrating that the exit rate for patients on lacosamide (400 mg/day) was significantly lower than historical control," the company said in a statement March 5. "UCB plans to submit these data as part of its supplemental New Drug Application to the US Food and Drug Administration, which is planned in the second half of 2013."

Full results of the trial will be presented "at an upcoming epilepsy meeting."

Conversion to Monotherapy

The phase 3 trial was an international, historical-controlled, multicenter, double-blind, randomized trial looking at lacosamide (400 mg/day) for conversion to monotherapy in 427 patients, aged 16 to 70 years, with partial-onset seizures who were already taking 1 or 2 other antiepileptic drugs (AEDs).

A lacosamide 300 mg/day group was added to blind the treatment group and to ensure a study design consistent with the historical control studies on which the conversion to lacosamide monotherapy study was based, the company notes.

The primary efficacy endpoint of the study was the percentage of patients who met at least 1 of the defined exit criteria by day 112 relative to the start of withdrawal of background AEDs and compared with the historical control. Patients were evaluated from the first day of tapering of the background AEDs and were required to discontinue the study if they experienced any of the protocol exit events, defined by seizure frequency, duration, or severity, the statement said.

The study met its primary endpoint, showing the exit rate for patients receiving lacosamide was significantly lower than that for the historical control group.

"We are very pleased with these top-line results and look forward to discussing the detailed study results with the regulatory agencies and the scientific community," Iris Loew-Friedrich, MD, PhD, chief medical officer and executive vice president at UCB said in the company's statement. "These encouraging data support our development program for lacosamide as monotherapy for partial onset seizures, starting in the United States."

Lacosamide is a Schedule V controlled substance. Full prescribing information can be found here.