UCB Announces New Data Showing Investigational Drug Lacosamide Significantly Reduced Seizures in Refractory Epileps...(t common adverse events associated with ...)

Patients in the SP754 trial had the option to transition to an open-label extension trial (SP615). The presentation of the SP615 data included an interim analysis of long-term efficacy and safety findings with lacosamide in 370 patients. The patients received lacosamide 100-800 mg/day based on the investigator's clinical judgment (median dose 400 mg/day). Of the 370 patients enrolled, 284 (76.8%) were exposed to lacosamide for more than 12 months, 224 (60.5%) for more than 24 months, and 140 (37.8%) for more than 36 months.

The study supported the long-term use (up to 5.5 years) of lacosamide as an adjunctive treatment in epilepsy patients with partial onset seizures, finding that the median percent reduction in seizure frequency across all prior treatment groups was 45.9%. Additionally, 46.6% of patients had at least a 50% reduction in seizure frequency with lacosamide.

The most common adverse events associated with lacosamide, occurring in 10% or more of patients, were dizziness, headache, fatigue, nasopharyngitis, diplopia, upper respiratory tract infection, nausea, abnormal coordination, contusion, vision blurred, vomiting, skin laceration, and sinusitis. Long-term lacosamide treatment was not associated with any pattern of change in hematology, clinical chemistry, vital sign, and body weight measurements with increasing duration of exposure. A small increase in median PR interval (5 to 9 msec) across all subjects (all modal doses) was observed on the ECG.

About Lacosamide: Lacosamide is a new chemical entity being developed as an oral and intravenous formulation for the treatment of partial-onset seizures.

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