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BioWorld - Wednesday, July 29, 2026
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Home » FDA green-lights SK’s Xcopri in epileptic seizures; gate for Arvelle with EMA
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FDA green-lights SK’s Xcopri in epileptic seizures; gate for Arvelle with EMA

Nov. 22, 2019
By Randy Osborne
On its PDUFA date Thursday, the FDA cleared Xcopri (cenobamate) tablets from South Korea’s SK Biopharmaceuticals Co. Ltd. to treat partial-onset seizures in adults. The drug’s mechanism of action is not fully understood, but it's believed to work through two separate mechanisms: enhancing inhibitory currents through positive modulation of GABA-A receptors and decreasing excitatory currents by inhibiting the persistent sodium current. 
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