SK Biopharm said on the 16th that its new epilepsy drug "cenobamate" showed positive results in a phase 3 trial for generalized seizures. Cenobamate is prescribed for adult patients with focal seizures. The company conducted the trial to expand the prescription population to adolescents and patients with generalized seizures.
The phase 3 trial was conducted in 12 countries, including the United States and Korea, with 169 adolescent and adult patients aged 12 and older. The patients had primary generalized tonic-clonic seizures (PGTG), a type of generalized seizure. The study evaluated efficacy and safety by comparing cenobamate with a placebo (dummy drug).
As a result, patients who received cenobamate as an add-on therapy saw a 71.9% reduction in seizure frequency. The placebo group saw a 39.6% reduction. The incidence of adverse events was similar between patients who received cenobamate (60%) and placebo (53%). Most adverse events were mild to moderate.
SK Biopharm will present detailed clinical results at the American Epilepsy Society (AES) in December. Based on these results, the company plans to apply to the U.S. Food and Drug Administration (FDA) for an expanded indication. SK Biopharm President Lee Dong-hoon said, "We are now able to offer a new treatment to more patients."