SK Biopharmaceuticals announced positive results from a phase 3 trial testing its epilepsy drug cenobamate in patients with generalized seizures, setting up a potential expansion of the treatment’s approved uses.
The South Korean drugmaker said cenobamate reduced seizure frequency by 71.9% compared with 39.6% for placebo in the 169-patient study targeting primary generalized tonic-clonic seizures. The company plans to seek U.S. regulatory approval to broaden the drug’s indication beyond its current use for partial-onset seizures.
The trial, conducted across 122 sites in 12 countries, represents SK Biopharm’s effort to maximize revenue from its flagship product as competition intensifies in the epilepsy market. The company generated 133.3 billion won ($94.5 million) from cenobamate sales in the first quarter, according to recent financial reports.
While the results appear encouraging, SK Biopharm faces the challenge of convincing regulators and physicians that the additional indication warrants approval given existing treatment options. The company has set ambitious targets, aiming for 1 trillion won ($708 million) in annual cenobamate revenue by 2029.
Treatment options for generalized seizures remain limited, according to company officials, though the FDA approval process typically requires extensive safety and efficacy documentation beyond phase 3 results. The detailed findings will be presented at the American Epilepsy Society meeting in December.
