12 March, 2025 /PRNewswire/

FINTEPLA® (fenfluramine) is an approved treatment for Dravet syndrome (DS), a rare and severe drug-resistant epilepsy.

The company announced today that it had published the findings from its long-term open-label extension (OLE) study in Epilepsia. The study, which evaluated the safety and efficacy of FINTEPLA, showed it was generally well tolerated and led to sustained reductions in seizure frequency in both children and adults with DS.

In summary:

Results demonstrated a statistically significant and clinically meaningful reduction in monthly convulsive seizure frequency (MCSF), with a median decrease of 66.8% from baseline (p<0.001).

Additionally, 64.2% of patients experienced a ≥50% reduction in seizures, and two patients remained seizure-free throughout the study. A significant 20.3% median increase in seizure-free days (p<0.0001) was also observed.

Long-term safety data showed that FINTEPLA was generally well tolerated, with only 2.9% of patients discontinuing due to adverse events. The most common treatment-emergent adverse events (≥10% of patients) included pyrexia, nasopharyngitis, decreased appetite, seizures, and upper respiratory infections. No cases of valvular heart disease or pulmonary arterial hypertension were reported.

Caregivers and investigators reported notable improvements in patient quality of life, including better energy levels, language skills, and general health.

Dravet syndrome (DS) is a rare, severe, drug-resistant epilepsy that begins in infancy and leads to developmental slowing or regression. Patients experience multiple seizure types and additional challenges such as cognitive impairment, speech and gait issues, and behavioral difficulties like impulsivity and hyperactivity, all of which impact quality of life.

Long-term findings on FINTEPLA® highlight its ability to provide sustained seizure reduction over 3.5 years. Brad Chapman of UCB emphasized the importance of addressing DS’s complexities,noting that these findings reinforce FINTEPLA’s long-term benefit in DS management, offering patients and caregivers a treatment option that provides durable seizure control and improved daily functioning.


For More on FINTEPLA® you can access the UCB site