Article published by Dravet Syndrome News
Fintepla (fenfluramine) is associated with dose-dependent, clinically meaningful improvements in everyday behavioral and emotional control, as well as the ability to adapt to new situations, in preschool-aged children with Dravet syndrome.
These benefits weren’t always tied to a clinically meaningful reduction in the frequency of seizures, suggesting the therapy may directly affect this patient population’s cognitive skills.
These are the findings of a posterior analysis of data from two completed Phase 3 clinical trials that supported the therapy’s approval in children and adults with Dravet.
The study, “Fenfluramine treatment is associated with improvement in everyday executive function in preschool-aged children (<5 years) with Dravet syndrome: A critical period for early neurodevelopment,” was published in Epilepsy and Behavior.
Dravet syndrome is a type of epilepsy marked by episodes of prolonged seizures starting in the first year of life. During preschool years, many children with the disease develop deficits in everyday executive function, the set of cognitive abilities needed for self-control, flexible thinking, and coordinating behavior, emotion, and cognitive capabilities.
These deficits make it critical to have an early intervention to prevent the disease’s impact on behavioral, emotional, and cognitive processes later in life.
Developed by Zogenix, now part of UCB, Fintepla is approved for treating seizures in adults and children 2 and older with Dravet. Data from previous Phase 3 trials showed that besides reducing seizure frequency, the therapy is associated with executive function improvements in patients aged 5 to 18. These post hoc analyses, done after the trials ended, didn’t assess everyday executive function changes in the 2- to 4-year-olds who participated.