Fintepla at low doses cuts Dravet seizures, small real-world study finds
Some with convulsive seizures able to stop, or at least reduce, other meds
Written by |
Treatment with Fintepla (fenfluramine) reduced convulsive seizures by at least half in nearly 60% of people with Dravet syndrome in a small, real-world study in Japan, with many responding at low doses, data show.
Among the patients who responded to Fintepla — approved in the Asian nation since 2022 for people ages 2 and older with Dravet — most were able to either stop or reduce another antiseizure medication, including Diacomit (stiripentol), without worsening of seizures, according to the findings of the retrospective study. The researchers noted that many Dravet patients are prescribed “a regimen of multiple [antiseizure medications] that is often associated with adverse events.”
“[Fintepla] effectively reduced convulsive seizures in [Dravet syndrome] even at low concentrations,” the researchers wrote in a section of the study labeled “Significance.”
For individuals with the rare condition, “we recommend the initiation of low-dose [Fintepla], which may allow dose reduction or discontinuation of [other] antiseizure medications,” the team wrote.
The study, “Efficacy and safety of fenfluramine in Dravet syndrome; A monocentric, observational study focused on initial dose, blood concentration, and reduction of concomitant medications,” was published in the journal Epilepsy & Behavior.
Dravet syndrome is a rare, severe form of epilepsy mainly caused by mutations in the SCN1A gene. Children with Dravet often require combinations of antiseizure medications, but seizures may remain hard to manage.
Over time, many patients develop developmental delays, coordination problems, and other neurological symptoms. Because seizures may contribute to cognitive decline and increase the risk of serious complications, improving seizure control is a major treatment goal.
Standard treatments have included various antiseizure medications, such as Diacomit, Depacon (valproate), and Onfi (clobazam). More recently, newer therapies such as Epidiolex (cannabidiol) and Fintepla (fenfluramine) have expanded treatment options for Dravet.
Fintepla originally used as appetite suppressant
Fintepla was originally used decades ago as an appetite suppressant, but it was withdrawn because of heart-related safety concerns at higher doses. The drug was later studied at much lower doses for Dravet syndrome, where it was shown to reduce seizures. The therapy was approved for Dravet in the U.S. and Europe in 2020, and, shortly thereafter, in Japan.
Now, researchers from the National Epilepsy Center in Shizuoka reviewed real-world data from people with Dravet who were treated with Fintepla. The team assessed seizure control, side effects, Fintepla blood levels, and whether outcomes differed if patients were also taking Diacomit, approved as an add-on therapy for those receiving Onfi.
In total, the study covered 27 patients with a median age of 14.9 years. Slightly more than half were female. All had started Fintepla between October 2022 and March 2025 for drug-resistant convulsive seizures. Each was taking at least two other antiseizure medications; 16 used Diacomit.
After starting Fintepla, more than 59% had at least a 50% reduction in convulsive seizure frequency. Seven patients (26%) had at least a 90% reduction — and five of them had seizure-free periods lasting more than three times longer than their usual seizure interval before Fintepla. Those intervals ranged from one month to 14 months, or longer than one year.
Most patients started Fintepla at a low dose. In the majority (89%), the initial dose was below 0.2 milligrams per kilogram of body weight per day (mg/kg/day). Among these individuals, 46% achieved at least a 50% seizure reduction at doses below that level.
Successful [Fintepla] therapy may allow tapering of less effective medications.
Fintepla’s effectiveness was not significantly different between patients who were or were not also taking Diacomit. Among those also using Diacomit, two-thirds had at least a 50% seizure reduction, compared with half of those not taking it.
Among the 16 patients who responded to Fintepla, doctors attempted to reduce or discontinue another antiseizure medication in about 8 of 10 cases. Six patients successfully discontinued one medication, and seven were still reducing a dose, the data showed. None of these medication reductions worsened seizures, the scientists noted.
According to the researchers, “successful [Fintepla] therapy may allow tapering of less effective medications.”
Gains seen for patients beyond seizure control
Families also reported improvements beyond seizure control with Fintepla use. Among patients with at least a 50% reduction in seizures, nine (56) showed improvements in cognition or behavior, most often better communication, such as more spontaneous speech or improved social interactions.
Side effects were reported for 63%. The most common was diarrhea, affecting 30%, followed by sleepiness, experienced by 22%, and decreased appetite, affecting 19%. Tremor was seen for 7%. One patient stopped Fintepla after experiencing seizure worsening and decreased appetite.
Testing showed that Fintepla could be effective even at relatively low blood levels. Among patients whose Fintepla blood levels were measured, all those with at least a 50% seizure reduction had levels below 80 nanograms per milliliter (ng/mL). Four responders had levels below 25 ng/mL.
Overall, these findings suggest that Fintepla “is likely to be effective for convulsive seizures even at a low dose and low [blood] concentration,” the researchers wrote. However, because Fintepla “concentrations tend to increase in adult patients and patients receiving concomitant [Diacomit], it may be necessary to consider titrating [Fintepla] from lower doses,” the team concluded.
Leave a comment
Fill in the required fields to post. Your email address will not be published.