New drugs for epilepsy! South Korea SK biopharmaceutical xcopri (cenobamate) has been approved by the FDA of the United States to treat some adult epilepsy!

November 25, 2019 / BIOON / -- SK biopharmaceuticals of South Korea and its US subsidiary SK Life Sciences recently jointly announced that the US Food and Drug Administration (FDA) has approved the xcopri (cenobamate) tablet for adult treatment of partial epilepsy In two fully controlled clinical studies, xcopri significantly reduced the frequency of partial seizure, and achieved zero seizure in up to 20% of patients during the maintenance period In particular, the approval marks the first time a Korean pharmaceutical company has independently pushed a drug from discovery to FDA approval Xcopri was discovered and developed by SK biopharmaceutical company and SK life science company Earlier this year, SK Biopharmaceutics signed an exclusive license agreement with arvelle therapeutics GmbH to develop and commercialize the drug in Europe Billy Dunn, director of the neuroscience Office of the FDA Center for drug evaluation and research, said: "xcopri is a new option for the treatment of partial epilepsy, which is often difficult to control and has a significant impact on the quality of life of patients Patients may have different reactions to various existing epilepsy drugs This approval provides additional necessary treatment options for groups with this disease " Cenobamate molecular structure formula (picture source: mechemexpress CN) the candidate drug component of xcopi is cenobamate, which is a sodium channel blocker At present, the exact mechanism of xcopri's therapeutic effect is not clear, but SK biopharmaceutical company believes that the drug can reduce repetitive neuron discharge by inhibiting voltage-gated sodium current, and it is also a positive allosteric regulator of GABAA ion channel The approval is based on the results of two global, randomized, double-blind, placebo-controlled studies (study 013, study 017) and a large, global, multicenter, open label safety study Study 013 included a 6-week drip and a 6-week maintenance period Data showed that a 200mg / day dose of xcopi reduced the median seizure frequency by 56%, while a 22% decrease in the placebo group; a post maintenance analysis showed that 28% of patients in the xcopi treatment group reported zero seizure, compared with 9% in the placebo group Study 017 included a 6-week drip period and a 12 week maintenance period The study included 100 mg / day, 200 mg / day and 400 mg / day dose xcopi The data showed that In the maintenance period, 4%, 11% and 21% of the patients in the three dose groups reported zero seizure, compared with 1% in the placebo group In terms of safety, the serious reactions related to xcopri include the drug reaction of eosinophilia and systemic symptoms (dress), QT shortening, suicide behavior and ideation, and adverse reactions of nervous system The most common (≥ 10% and higher than placebo) treatment-related adverse events were drowsiness (drowsiness), dizziness, fatigue, diplopia (binocular vision), and headache According to the Centers for Disease Control and Prevention (CDC), about 3 million adults in the United States have epilepsy, and about 60% of them report epilepsy despite taking AEDs Epilepsy is usually a short-term abnormal electrical activity in the brain, which can lead to uncontrolled movement, abnormal thinking or behavior and abnormal feeling The movement may be intense and the patient may lose consciousness Some seizures begin in a limited area of the brain Xcopri is expected to be available in the United States in the second quarter of 2020 The drug has six dose intensities, once a day: 12.5mg, 25mg, 50mg, 100mg, 200mg In terms of medication, xcopri should be started with 12.5mg, titrated once a day and every two weeks After the drug adjustment period, the recommended maintenance dose is 200 mg / day, but some patients may need to adjust to 400 mg / day, which is the maximum recommended dose Xcopri can be used in combination with other antiepileptic drugs or alone The long-term security of xcopri has been evaluated in the open label extension of the randomized and open label security studies Other clinical trials are investigating the therapeutic role of xcopri in other types of epilepsy Original source: FDA approvals xcopri ® (cenobamate tables), an anti epileptic drug (AED) from SK biopharmaceuticals, Co., Ltd., and U.S subsidiary SK life science, Inc