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FDA approves XCOPRI for partial-onset seizures
The FDA recently approved XCOPRI for adults with partial-onset seizures, its manufacturer announced.
“The approval of XCOPRI will provide clinicians with an effective medication for our patients who are continuing to have focal (partial onset) seizures,” Michael Sperling, MD, director of the Jefferson Comprehensive Epilepsy Center at Jefferson Health in Philadelphia, said in a press release.
According to the release, approximately 3 million adults live with epilepsy in the United States, and nearly 60% reported still having seizures despite taking an antiepileptic drug.
XCOPRI’s (cenobamate tablets, SK Biopharmaceuticals) approval was based on two studies, the company said.
In the first study, 113 patients who received 200 mg of cenobamate daily and completed a 6-week titration phase followed by a 6-week maintenance phase had a 56% drop in median seizure frequency vs. a 22% reduction among those who received placebo. A post-hoc analysis performed during the maintenance phase showed that 28% of patients who received cenobamate had zero seizures vs. 9% of patients who received placebo.
In the second study, 328 patients were randomly assigned in an approximate 1:1:1 ratio to receive either 100 mg, 200 mg or 400 mg of cenobamate daily for 6 weeks titration, followed by 12 weeks of maintenance. The median seizure frequency reduction was 36%, 55% and 55% in those who received 100 mg, 200 mg and 400 mg, respectively, vs. 24% who received placebo. In addition, 4% of patients in the 100 mg daily cohort, 11% of patients in the 200 mg daily cohort, 21% of patients in the 400 mg daily cohort and 1% of patients in the placebo cohort reported zero seizures.
Cenobamate is expected to be available in the United States in the second quarter of 2020, the release stated. A spokesperson for SK Life Science, a subsidiary of SK Biopharmaceuticals, told Healio Primary Care that the company has not yet determined the list price for XCOPRI. – by Janel Miller
Disclosures: Sterling was a clinical investigator in cenobamate’s development.