The Food and Drug Administration (FDA) has accepted the new drug application (NDA) filing for cenobamate (SK life science; Fair Lawn, NJ), an investigational antiepileptic drug for the treatment of partial-onset seizures in adults.
The NDA submission is based on data from pivotal clinical trials that enrolled more than 1,900 patients. The findings were presented at medical conferences including the annual meetings of the American Academy of Neurology (AAN) and the American Epilepsy Society (AES). The drug’s mechanism of action is not fully understood, but it is believed to work through two separate mechanisms: enhancing inhibitory currents through positive modulation of GABAAreceptors and decreasing excitatory currents by inhibiting the persistent sodium current.
“The FDA’s acceptance of our NDA filing is a critical step toward our goal of introducing a new treatment option for people with uncontrolled epilepsy,” said Marc Kamin, MD, chief medical officer at SK life science. “We look forward to working with the FDA during their review of our data on cenobamate.”
Monideep Dutt, MD; Jamika Hallman-Cooper, MD; Ekta Bery, MD; Mohammed Shahnawaz, MD; and Grace Gombolay, MD
Michelle L. Dougherty, MD, FAES, FAAN
James Geyer, MD, and Paul Cox