Today’s approval was based on results from two randomized controlled trials that included more than 600 patients, the agency said in a press release.
“Xcopri is a new option to treat adults with partial-onset seizures, which is an often difficult-to-control condition that can have a significant impact on patient quality of life,” Billy Dunn, MD, director of the Office of Neuroscience in the Center for Drug Evaluation and Research at the FDA, said in a statement.
As reported by Medscape Medical News, results from one of the studies upon which today’s approval was based were published online last week in Lancet Neurology. The findings showed that both primary endpoints were met.
Although most treatment-emergent adverse events (AEs) were reported to be mild to moderate in severity, one of these participants receiving the 200 mg dose had a drug reaction with eosinophilia and systemic symptoms (DRESS).
In an open-label safety trial of 1339 participants that was also reviewed by the FDA, there were no cases of DRESS when patients started cenobamate at 12.5 mg per day and the dose was adjusted every 2 weeks.
Because more patients who took the drug than those taking placebo had a shortening of the QT interval greater than 20 milliseconds, cenobamate shouldn’t be used in those with hypersensitivity to the drug “or any of the inactive ingredients in Xcopri or Familial Short QT syndrome,” the agency writes, adding that QT shortening can be associated with ventricular fibrillation, a serious heart rhythm problem.
The FDA also notes that any patient taking an antiepileptic drug should be monitored for the emergence or worsening of depressive symptoms, suicidal thoughts or behaviors, or any other changes in mood.
The most common AEs reported in the trials were somnolence, dizziness, fatigue, and diplopia (double vision).
“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, professor of neurology and director of the Jefferson Comprehensive Epilepsy Center, Philadelphia, Pennsylvania, and an investigator in the drug‘s clinical development program, said in a press release from SK Life Science.
“It is very encouraging to see that patients receiving Xcopri saw significant reductions in frequency of seizures, with some even achieving zero seizures,” Sperling added.
“There is an urgent need to advance research and introduce new treatment options. The FDA approval of Xcopri for the treatment of partial-onset seizures is a welcome option for the epilepsy community,” Beth Lewin Dean, chief executive officer of Citizens United for Research in Epilepsy, said in the same release.
SK Life Science noted in a statement that the drug is expected to be available in the United States in the second quarter of 2020 “following scheduling review” by the US Drug Enforcement Administration.