Posted by Michael Wonder on 05 Feb 2019
SK Life Science announces FDA acceptance of NDA submission for cenobamate, an investigational anti-epileptic drug
4 February 2019 - SK Life Science announced today that the U.S. FDA has accepted the filing of its new drug application for cenobamate.
Cenobamate, an investigational anti-epileptic drug for the potential treatment of partial-onset seizures in adult patients, is the first molecule discovered and developed from inception through to the submission of an application without partnering or out-licensing from a Korean pharmaceutical company. SK Life Science plans to commercialise cenobamate independently.
The submission is based on data from pivotal trials that evaluated the efficacy and safety of cenobamate.
