SK Life Science Inc., a subsidiary of SK Biopharmaceuticals Co., Ltd., a pharmaceutical company focused on developing treatments for central nervous system (CNS) disorders, announced that the results of the long-term, open-label extension (OLE) of a randomized, double-blind, placebo-controlled study (C017) of XCOPRI® (cenobamate) were published online in the journal Neurology.
The OLE phase analyzed data from 355 adult patients with uncontrolled focal seizures despite treatment with 1-3 antiseizure medications (ASMs) who completed the 18-week C017 double-blind phase and entered the OLE. Patients included in the study also had ≥8 seizures during the 8-week baseline period. Results from the study showed the long-term clinical efficacy and safety of cenobamate for adult patients with partial-onset (focal) seizures. Among the 355 patients who received at least one dose of cenobamate, the median treatment duration was 54 months (200 mg median modal daily dose, range 50 mg to 400 mg). As of the data cut-off in July 2019, 59% (209/355) patients continued on treatment with cenobamate.
Retention rates for patients who were enrolled at 12, 24, 36, and 48 months in the study were 83%, 71%, 65%, and 62%, respectively. Additionally, among the observed patients during any 12-month period, 13% to 16% of patients achieved seizure freedom. Among patients who achieved 100% seizure reduction, the median duration of seizure freedom during each 12-month interval was 48 months, 47.2 months and 45.1 months, respectively. Patients taking cenobamate experienced a median percent seizure frequency reduction over baseline that increased with each 6-month interval, up to 76% (IQR: 45%), during months 43-48 of the OLE.