February 5, 2019

FDA to Review Cenobamate for the Treatment of Partial-Onset Seizures

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The 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.

The NDA submission includes results from a clinical trial program which 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.

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