The FDA approved Nov. 21 SK Life Science's drug, Xcopri, designed to treat partial-onset seizures in adults.
During a clinical trial, Xcopri reduced the percent of seizures per 28 days compared to the placebo group.
Multiorgan hypersensitivity was reported among some patients in the clinical trial and one patient died when the drug was titrated faster than usual. Some patients also had shortening of an electrical measurement in the heart, known as the QT interval. QT shortening can cause ventricular fibrillation, a serious heart rhythm problem.
Xcopri should not be used in patients with hypersensitivity to cenobamate or any of the inactive ingredients in Xcopri or Familial Short QT syndrome.
Antiepileptic drugs such as Xcopri can cause an increased risk of suicidal thoughts or behavior. Patients should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior and any unusual changes in mood or behavior.
Xcopri may also cause sleepiness, fatigue, dizziness, trouble walking, coordination issues, trouble with thinking and visual changes. Patients shouldn't drive until they see how they react to the drug.
Read the full news release here.
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