Anup Patel, MD: In this pivotal subanalysis we really wanted to look at the safety as it relates to children being exposed to brivaracetam during the pivotal trials. Not much literature existed as it relates to pediatric patients and their exposure to brivaracetam. This is one of the first key studies that shows that this medication was well tolerated by patients being given brivaracetam. The median dose was around 4 mg/kg per day, which does suggest that a good dose of this medication can be tolerated by patients, and the adverse effect profile was not alarming. The most common adverse events were very similar to what you see with other antiseizure medications, and that includes tiredness, fever, and decreased appetite.
What we found was significant, as it relates to the brivaracetam data in children, is that this medication can be tolerated very well for patients with focal seizures that either become secondary generalized or don’t generalize. It gives us some of the first information that has been published as it relates to pediatric patients and their tolerability for brivaracetam. This medication is a safe option, and this study and abstract we just presented have proven that exact finding.