New Treatment for Adults with Partial-Onset Seizures Granted FDA Approval

The FDA has approved cenobamate tablets (XCOPRI, SK Life Sciences) for treatment of partial-onset seizures in adults.

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According to Billy Dunn, MD, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, the condition is difficult to control and can have a significant impact on patient quality of life.

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“Patients can have different responses to the various seizure medicines that are available. This approval provides an additional needed treatment option for people with this condition,” said Dunn, in a prepared statement.

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“Approximately 3 million adults live with epilepsy in the US and, according to the Centers for Disease Control and Prevention (CDC), nearly 60% reported having seizures, even if they took an AED,” said Beth Lewin Dean, Chief Executive Officer of Citizens United for Research in Epilepsy (CURE), in a prepared statement.

“There is an urgent need to advance research and introduce new treatment options.”

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The safety and efficacy of cenobamate tablets to treat partial-onset seizures was established in 2 randomized, double-blind, placebo-controlled studies

that enrolled 655 adults. In these studies, patients had partial-onset seizures with or without secondary generalization for an average of approximately 24 years, and median seizure frequency of 8.5 seizures per 28 days during an 8-week baseline period.

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During the trials, doses of 100, 200, and 400 milligrams (mg) daily of cenobamate tablets reduced the percent of seizures per 28 days compared with the placebo group. The recommended maintenance dose of cenobamate tablets, following a titration period, is 200 mg daily. Some patients may need an additional titration to 400 mg daily, the maximum recommended dose, based on their clinical response and tolerability, according to the FDA.

The most common adverse effects reported in the clinical trials were sleepiness, dizziness, fatigue, double vision, and headaches.

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Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported among patients taking cenobamate tablets. In the clinical trials, some patients experienced DRESS, and 1patient died when cenobamate tablets were titrated rapidly (weekly or faster titration), according to the FDA. No cases of DRESS were reported in an open-label safety study of 1339 epilepsy patients when cenobamate tablets were started at 12.5 mg per day and adjusted every 2 weeks; however, this finding does not show that the risk of DRESS is prevented by a slower titration.

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Antiepileptic drugs (AEDs), including cenobamate tablets, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients taking an AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

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Today’s approval marks the first time a Korean company has independently brought a compound from discovery to U.S. FDA approval.

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According to SK Life Sciences, the company’s cenobamate tablets are expected to be available in the US in the second quarter of 2020.

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REFERENCES

1. FDA approves new treatment for adults with partial-onset seizures [news release]. Silver Spring, MD; November 21, 2019: FDA website. https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-adults-partial-onset-seizures. Accessed November 21, 2019.
2. FDA Approves XCOPRI® (cenobamate tablets), an Anti-Epileptic Drug (AED) from SK Biopharmaceuticals, Co., Ltd., and U.S. Subsidiary SK Life Science, Inc. [news release]. Pangyo, Gyeonggi Province, Korea and Paramus, NJ; November 21, 2019: SK Biopharmaceuticals website. https://www.skbp.com/eng/news/view.do?boardSeq=453&boardCode=BDCD0002. Accessed November 21, 2019.