A new Phase 3 trial has demonstrated that Fintepla (fenfluramine) significantly reduces seizure frequency in children and adolescents with Dravet syndrome who experience hard-to-treat seizures. The study, funded by Zogenix and published in Epilepsia, adds to the growing body of evidence supporting the benefits of Fintepla as an add-on therapy for this pediatric patient population.
The trial enrolled 143 children and adolescents with Dravet syndrome, aged 2-18, who had seizures not completely controlled by their current medications. Participants were randomly assigned to receive either oral Fintepla or a placebo, given daily. The treatment period lasted for 12 weeks.
The results showed that Fintepla led to a 65% greater reduction in convulsive seizure frequency compared to placebo. Patients treated with Fintepla also experienced significantly longer seizure-free intervals. Additionally, those in the higher-dose group (0.7 mg/kg) saw a greater drop in seizure frequency compared to the lower-dose group (0.2 mg/kg).
The study found that Fintepla was generally well-tolerated, with mild or moderate side effects such as diarrhea, fatigue, and decreased appetite. No cardiovascular issues were observed.
The findings confirm the robust antiseizure response of Fintepla in the treatment of Dravet syndrome. The results are consistent with previous Phase 3 trial reports and provide further evidence of the efficacy and durability of Fintepla as an add-on therapy for children and adolescents with this rare form of epilepsy.
It is worth noting that Fintepla was approved by the U.S. Food and Drug Administration in 2020 as an add-on treatment for seizures in Dravet patients aged 2 and older. It is also approved for use in the European Union and Japan.
Further studies, including an open-label extension study, have shown that the benefits of Fintepla are sustained with long-term treatment.
Sources:
– Study: “Fenfluramine in the treatment of Dravet syndrome: Results of a third randomized, placebo-controlled clinical trial” (Epilepsia)
– Funding: Zogenix
– FDA Approval: U.S. Food and Drug Administration
