FDA approves Xcopri to treat partial-onset seizures in adults. - SK Biopharma
SK Biopharmaceuticals, Co., Ltd., and its U.S. subsidiary SK Life Science, Inc. announced that the FDA approved Xcopri (cenobamate tablets) as a treatment for partial-onset seizures in adults.
The approval is based on results from two global, randomized, double-blind, placebo-controlled studies 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 the randomized studies (Study 013 and Study 017), Xcopri demonstrated significant reductions in seizure frequency compared to placebo at all doses studied.
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