UCB has started a new Phase III trial of lacosamide in Japan and China, designed to investigate the efficacy and safety of the drug as adjunctive therapy in adult patients with partial onset seizures. UCB obtained Japanese rights to lacosamide at the end of 2010, and currently holds the worldwide rights to development and marketing. Initial results from the Phase III study are expected in the first half of 2015.
The double-blind, randomised, placebo-controlled, 27-week study will examine the efficacy and safety of lacosamide administered concomitantly with one to three antiepileptic drugs, and will be evaluated in approximately 540 adult patients in Japan and China who have uncontrolled partial onset seizures, with or without secondary generalisation. The primary outcome measure is the change in partial onset seizure frequency per 28 days from baseline to the end of the maintenance period. Secondary efficacy variables include responder rate, measured by percentage of patients achieving a >=50 per cent reduction in partial onset seizure frequency per 28 days from baseline to the maintenance period.
Lacosamide is currently not approved in Japan or in China for the treatment of epilepsy. However, it was first launched in the EU in September 2008, as adjunctive therapy for the treatment of partial onset seizures, with or without secondary generalisation, in adult and adolescent (16 to 18 years) patients with epilepsy and is available as film-coated tablets, syrup and solution for infusion. Lacosamide solution for infusion is an alternative for patients when oral administration is temporarily not feasible. In the US, lacosamide tablets and injection were launched in May 2009 as an adjunctive therapy for the treatment of partial onset seizures in people with epilepsy who are aged 17 years and older. Lacosamide oral solution was subsequently launched in June 2010.