ATLANTA, Dec. 3 /PRNewswire/ -- UCB today announced new data demonstrating that the investigational drug lacosamide, with the proposed brand name Vimpat(TM), administered as oral, adjunctive therapy, significantly reduced the frequency of seizures and was generally well-tolerated in patients with uncontrolled partial-onset seizures, for up to 5.5 years. The results of the two Phase II trials (Abstracts 3.197 and 3.191) were presented today at the 61st annual meeting of the American Epilepsy Society.
"These findings are encouraging because they show lacosamide significantly reduced seizure frequency in this refractory patient population over a long-term period," said Steve S. Chung, Director of Clinical Epilepsy Research at the Barrow Neurological Institute in Phoenix. "Approximately one third of people with epilepsy are resistant to current antiepileptic drugs. These data show lacosamide's potential to fill an unmet need in this patient population."
The first presentation (SP754) was a double-blind, randomized, parallel-group, placebo-controlled Phase II trial involving 405 patients with refractory partial onset seizures, which were uncontrolled despite treatment with one to three AEDs. The patients were randomized to receive lacosamide 400 mg/day or 600 mg/day (given in 2 doses), or placebo over the 12-week treatment period.
The median reduction in seizure frequency from baseline was significantly greater for lacosamide than placebo: 37.3%, 37.8% and 20.8% for lacosamide 400 mg/day, 600 mg/day, and placebo, respectively. Significantly more patients achieved a 50% or greater reduction in seizure frequency with lacosamide than placebo: 38.3%, 41.2% and 18.3% for lacosamide 400 mg/day, 600 mg/day, and placebo, respectively. Nine subjects who completed the Maintenance Phase were seizure free throughout the entire 12-weeks: 4 of 160 completers in the 400 mg/day group (2.5%) and 5 of 62 completers in the 600 mg/day group (8.1%).
|SOURCE UCB, Inc.|
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