The Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for cenobamate (SK Life Science), an investigational antiepileptic drug being developed for the treatment of partial-onset seizures in adults.

While the exact mechanism of action of cenobamate is not fully understood, it is believed to work through a dual mechanism, enhancing inhibitory currents through GABAA receptor modulation, and decreasing excitatory currents by inhibiting the persistent component of the sodium current.

The NDA submission includes results from a clinical trial program that included over 1900 patients. Adjunctive treatment with cenobamate was found to significantly decrease seizure frequency in 2 well-controlled studies, however cases of drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome were reported in early clinical development among the first patients exposed to the drug. In December 2018, results from a large Phase 3 safety study showed that among the 1037 patients exposed to cenobamate, no cases of DRESS were identified; reducing the starting dose and slowing titration rate appeared to reduce the risk.

Chief medical officer of SK Life Science, Marc Kamin, MD said, “We look forward to working with the FDA during their review of our data on cenobamate.” A Prescription Drug User Fee Act target date has been set for November 21, 2019.

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