SK Biopharmaceuticals said on the 24th that its U.S. subsidiary SK Life Science will present 10 studies related to the epilepsy treatment cenobamate and host a symposium at the 2025 American Epilepsy Society (AES) annual meeting, to be held in Atlanta from Dec. 5 to 9.
At this meeting, a phase 3 study of primary generalized tonic-clonic seizures (PGTC) in adolescents and adults was selected as a late-breaking abstract (LBA) and will be presented. SK Biopharmaceuticals said it will present data to demonstrate cenobamate's potential as a broad-spectrum antiseizure medication based on the topline results for generalized seizures released in Sep.
In addition, clinical results for a new formulation of the oral tablet—a suspension—will also be disclosed. According to the findings, bioavailability was similar between the tablet and the suspension, and dosing was possible regardless of food intake. The company plans to submit a new drug application (NDA) for the oral suspension formulation within the year.
In a pharmacokinetic (PK) analysis of patients aged 12 to 18 with focal seizures, drug exposure similar to the approved adult dose was confirmed, providing evidence to support a potential label expansion to ages 12 and older.
During the meeting, SK Life Science will hold a symposium titled "Shining a new path to seizure reduction," highlighting the evolution of treatment for drug-resistant epilepsy and the role of third-generation antiseizure medications.
Sunita Misra, SK Life Science's vice president of global clinical development and medical, said, "AES 2025 is a venue to clinically confirm cenobamate's potential to treat generalized seizures and to explore directions for innovation in epilepsy treatment with experts worldwide," adding, "We will present the potential of a new treatment option to clinicians and patients through these clinical data."