The FINANCIAL — Daiichi Sankyo Company, Limited and UCB Japan Co., Ltd. announced that the results of analysis of data from the clinical trial of lacosamide (Generic Name) were presented at 2015 Annual Meeting of the American Epilepsy Society held on December 4-8, 2015, in Philadelphia, USA.
This Phase III trial was a double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of adjunctive lacosamide treatment in Chinese and Japanese adult epilepsy patients with uncontrolled partial-onset (focal) seizures (POS) with or without secondary generalization. The study met its primary endpoint for the change in POS frequency per 28 days from baseline to maintenance in the lacosamide 200 mg/day and 400 mg/day. The proportions of patients with at least a 50% reduction in POS frequency during maintenance for lacosamide were statistically significant when compared to placebo. In addition, during the maintenance period a greater proportion of seizure free patients was observed in the lacosamide groups versus placebo. The observed adverse events were similar to those reported in previous lacosamide studies and post marketing surveys, according to Daiichi Sankyo Company.
When marketing authorization is obtained, UCB Japan and Daiichi Sankyo will take care of manufacturing and sales/distribution, respectively, in Japan, while the two companies will jointly carry out promotion based on the joint commercialization agreement concluded by the companies in November 2014.
Daiichi Sankyo and UCB Japan hope to contribute to epilepsy patients and healthcare providers in Japan by providing a new option for adjunctive therapy in the treatment of partial-onset seizures.
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