SK Pharmaceuticals and its U.S. subsidiary, S.K. Life Sciences, announced the U.S. FDA has approved Xcopri (cenobamate tablets) as a treatment for partial-onset seizures in adults. Xcopri is expected to be available in the U.S. in the second quarter of 2020, following scheduling review by the U.S. Drug Enforcement Administration (DEA).
The FDA approval of Xcopri was based on results from two global, randomized, double-blind, placebo-controlled studies (Study 013 and Study 017) and a large, global, multi-center, open-label safety study that enrolled adults with uncontrolled partial-onset seizures, taking one to three concomitant anti-epileptic drug (AEDs).
In Study 013, which included a 6-week titration phase followed by a 6-week maintenance phase, a statistically significant 56% reduction in median seizure frequency was seen with Xcopri 200 mg/day (n=113) versus a 22% reduction with placebo (n=108). During the maintenance phase of Study 013, a post-hoc analysis showed that 28% of patients receiving XCOPRI had zero seizures, compared with 9% of placebo patients. In Study 017, which included a 6-week titration phase followed by a 12-week maintenance phase, patients randomized to Xcopri 100 mg/day (n=108), 200 mg/day (n=109) or 400 mg/day (n=111) had statistically significant 36%, 55% and 55% reductions in median seizure frequency, respectively, versus a 24% reduction with placebo (n=106). During the maintenance phase of Study 017, 4% of patients in the Xcopri 100 mg/day group, 11% of patients in the Xcopri 200 mg/day group, 21% of patients in the Xcopri 400 mg/day group and 1% of patients in the placebo group reported zero seizures.
Serious reactions associated with Xcopri include drug reaction with eosinophilia and systemic symptoms (DRESS), QT shortening, suicidal behavior and ideation, and neurological adverse reactions. The most common (≥10% and greater than with placebo) treatment-emergent adverse events associated with Xcopri include somnolence (sleepiness), dizziness, fatigue, diplopia (double vision) and headache.
About Xcopri (cenobamate tablets)
While the precise mechanism by which Xcopri exerts its therapeutic effect is unknown, Xcopri is believed to reduce repetitive neuronal firing by inhibiting voltage-gated sodium currents. It is also a positive allosteric modulator of the γ‑aminobutyric acid (GABAA) ion channel.
Epilepsy is a common neurological disorder characterized by seizures. There are approximately 3 million adults in the U.S. living with epilepsy and approximately 60% have partial-onset seizures, which begin in just one part of the brain. People with epilepsy are at risk for accidents and other health complications including falling, drowning, depression and sudden unexplained death in epilepsy (SUDEP). Despite the availability of many antiepileptic therapies, approximately 40% of adults with partial-onset seizures have inadequate control of their seizures, even after treatment with two anti-epileptic drugs (AEDs).