FDA Approves Cenobamate for Partial-Onset Seizures

November 22, 2019

Approved for patients 18 years of age and older

The FDA has approved cenobamate tablets (Xcopri) for the treatment of partial-onset seizures in patients 18 years of age and older. 

Cenobamate was discovered and developed by SK Life Sciences, a subsidiary of Korean-based SK Biopharmaceuticals. 

According to a statement from SK Life Sciences, the precise mechanism of action of cenobamate is still unknown. The molecule is believed to reduce repetitive neuronal firing by inhibiting voltage-gated sodium currents. Cenobamate is also a positive allosteric modulator of the ƛ-aminobutyric acid (GABAA) ion channel. 

“Approximately 3 million adults live with epilepsy in the U.S. 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, CEO of Citizens United for Research in Epilepsy (CURE) in a statement. “There is an urgent need to advance research and introduce new treatment options. The FDA approval of XCOPRI for the treatment of partial-onset seizures is a welcome option for the epilepsy community.”

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“Today’s approval is a major step toward our goal of becoming a fully-integrated global pharmaceutical company that can discover, develop, and deliver new treatment options in epilepsy and CNS,” said Jeong Woo Cho, PhD, President and CEO of SK Biopharmaceuticals and SK Life Science in a statement. “We are grateful to the thousands of participants in our trials, clinical investigators, partners in the epilepsy community and our employees for their important contributions in bringing forward this treatment option for adults with partial-onset seizures.”

Approval was based upon the results of two global, randomized, double-blind, placebo-controlled studies (Study 013 and Study 017) and a large, global, multi-center open-label safety study, SK said in a release. 

Generally, cenobamate demonstrated significant reductions in seizure frequency compared with placebo at all doses studied. 

Study 013: 6-week titration followed by 6-week maintenance. Dose = 200 mg/day. (N=113)

  • Placebo: 22% reduction 

  • Xcopri: 56% reduction in median seizure frequency

Study 017: 6-week titration followed by 12-week maintenance. Dose = 100 mg/day. (N=106)

  • Placebo: 24% reduction in median seizure frequency

  • Xcopri 100 mg: 36% reduction in median seizure frequency

  • Xcopri 200 mg: 55% reduction in median seizure frequency

  • Xcopri 400 mg: 55% reduction in median seizure frequency

Cenobamate is contraindicated in patients with known allergic reactions to cenobamate or any of the ingredients in Xcopri. 

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In the official release, SK warns of serious skin rash or other hypersensitivity reactions, QT shortening, suicidal behavior and ideation (1 in 500 patients), decreased effectiveness of birth control medication, and other nervous system problems that may arise as a result of treatment with cenobamate. 

 

Adverse events reported with the use of cenobamate include: dizziness, sleepiness, headache, double vision, and drowsiness/fatigue.