UCB has presented positive clinical results from a Phase III clinical study of Vimpat (lacosamide), designed for the treatment of adult patients with partial-onset seizures with or without secondary generalisation.
Available in tablets and injection forms, Vimpat (lacosamide) is approved as an adjunctive therapy for the treatment of partial-onset seizures in adults with epilepsy (aged 17 and over in the US, and 16 and over in the EU).
The international, multicentre, double-blind, randomised study evaluated the efficacy and safety of lacosamide (400mg/day) for conversion to monotherapy in 427 patients aged 16-70 years, with partial-onset seizures taking one to two other anti-epileptic drugs (AEDs), compared with a historical control.
The primary efficacy endpoint of the study was the percentage of patients who met at least one of the defined exit criteria by day 112, relative to the start of withdrawal of background antiepileptic drugs and compared with the historical control, according to the company.
The study met its primary endpoint, showing that the exit rate for patients on lacosamide (400mg/day) was significantly lower than the historical control.
UCB chief medical officer and executive vice president Dr Iris Loew-Friedrich said the company is looking forward to discuss the detailed study results with the regulatory agencies and the scientific community.
"These encouraging data support our development program for lacosamide as monotherapy for partial onset seizures, starting in the United States," Loew-Friedrich said.
The company said it will include the data in its supplemental new drug application for lacosamide, and submit to the US Food and Drug Administration (FDA) in the second half of 2013.
Image: UCB will be submitting a new drug application for lacosamide to the FDA later this year. Photo: Courtesy of UCB.