SK Life Science, Inc., a U.S. pharmaceutical company developing treatments for central nervous system (CNS) disorders and a subsidiary of SK Biopharmaceuticals Co., Ltd., has officially confirmed the publication of a sponsored supplement on Epilepsia, which happens to be a leading journal in the field, focused on improving outcomes for people with epilepsy.
Going by the available details, this particular supplement has been meticulously designed to offer in-depth overview of new epilepsy treatment, including XCOPRI® (cenobamate tablets) CV and data for these treatments on sustained seizure control, mortality, sudden unexpected death in epilepsy (SUDEP) risk, and the impact XCOPRI has had with patients worldwide.
“XCOPRI provides an alternative approach to the challenging and often complex treatment of partial-onset seizures, offering some patients the possibility of sustained seizure control—or even seizure freedom,” said Louis Ferrari, BS, RPh, MBA, vice president, Medical Affairs at SK Life Science. “As of September 2024, more than 175,000, patients globally have been treated with XCOPRI, and there is a growing body of evidence supporting the profound impact it can have for others who continue to struggle with ongoing seizures.”
Talk about the whole value proposition on a slightly deeper level, we begin from prospect of sustained efficiency and tolerability. In essence, if we asses long-term open label extension data of adjunctive XCOPRI for ≥4 years in adults, it will effectively show up to 16.4% of patients achieving seizure freedom.
Beyond that, a post-hoc analysis of people with drug-resistant epilepsy, treated with more than two anti-seizure medications (ASMs) at baseline, also showed that approximately 1 in 5 patients experienced seizure freedom during the maintenance phase in the 400 mg/day dose group.
In fact, assuming you conduct a post-hoc efficacy analysis of older adults with focal epilepsy from a Phase 3 safety trial, you would get to know that 78.6% achieved seizure freedom with XCOPRI at months 21-24, and while rates of dizziness and falls occurred more commonly in older patients compared to the overall population, they were lower than observed in subgroup analyses of other ASMs.
Next up, the publication preached the deployment of aggressive treatment strategies to prevent high risk focal to bilateral tonic-clonic seizures (FBTCS). You see, during a post-hoc analysis from a Phase 3 XCOPRI safety study, nearly 35% of all patients, who entered maintenance dosing with FBTC seizures, clocked a staggering 100% reduction in FBTC seizures.
Not just that, recent analysis of more than 2,100 patients in nine completed or ongoing Phase 2 or 3 trials showed that the standardized mortality ratio (SMR) for XCOPRI patients was statistically indistinguishable from the SMR for the general population and from seizure-free patients.
Moving on, SK Life Science’ study would also reveal that flexible dosing, understanding potential drug-drug interactions and concomitant medication management can enhance tolerability. We get to say so because one-year retention rates with adjunctive XCOPRI in open-label clinical studies range from 73%-83%.
Such benefit of titration allows for specific, individualized dosing and modifications to concomitant medications.
Rounding up highlights would be a piece of data, claiming that discontinuing, rather premature, those ASMs like XCOPRI could very well lead to an inadequate assessment of efficacy. Instead, one must leverage strategies like reducing the number and doses of concomitant ASMs first to properly assess new treatment effectiveness, and at the same time, avoid improper labeling of drug-resistance.
“Today, with the approval of newer medicines that have demonstrated impressive efficacy and safety, long-term seizure freedom is more possible than ever for people with drug-resistant epilepsy. Yet, these medicines are underutilized or not introduced when they could have the greatest impact,” said Patrick Kwan, PhD, FRACP, Professor of Neurology at Monash University in Melbourne, Australia, who co-edited the Epilepsia supplement. “With some newer agents not yet included in professional treatment guidelines, this collection of articles provides clinicians with a comprehensive review of relevant data and practical strategies to proactively incorporate and manage innovative antiseizure medications earlier in treatment.”