Atlanta, Georgia, August 5, 2026
UCB has announced the publication of a post hoc analysis in Epilepsia Open demonstrating that FINTEPLA® (fenfluramine) delivered rapid and sustained improvements in seizure control and global functioning among patients with Lennox-Gastaut syndrome (LGS). The analysis evaluated patients transitioning from a randomized placebo-controlled Phase 3 trial into an open-label extension (OLE) study, providing new insights into the treatment trajectory of FINTEPLA over time. Results showed that patients initiating FINTEPLA after placebo experienced meaningful reductions in seizure frequency within the first month of therapy, while patients continuing treatment maintained consistent long-term clinical benefits. Safety findings remained aligned with the medicine’s established profile, supporting the continued use of FINTEPLA in eligible patients with LGS. These findings offer clinicians and caregivers valuable real-world evidence regarding treatment response, dose optimization, and long-term disease management in one of the most challenging pediatric neurological disorders.
FINTEPLA Demonstrates Rapid and Sustained Seizure Reduction
The published analysis included 151 patients who completed 12 months of treatment in the open-label extension after participating in the original Phase 3 randomized controlled trial. Investigators evaluated seizure frequency, clinician- and caregiver-assessed global functioning using the Clinical Global Impression–Improvement (CGI-I) scale, and long-term safety outcomes. Patients who transitioned from placebo to FINTEPLA experienced a 32.1% median reduction in seizures associated with falls after one month, with seizure reductions improving further during continued treatment. Participants who had received FINTEPLA throughout both study phases maintained similarly robust seizure control, reinforcing the durability of treatment benefits. By Month 12, more than half of patients demonstrated clinically meaningful improvements in overall functioning, highlighting benefits extending beyond seizure reduction alone. These findings provide important evidence supporting early initiation and sustained treatment with FINTEPLA in patients living with Lennox-Gastaut syndrome.
Long-Term Safety Supports Continued Treatment
The safety profile observed during the open-label extension remained consistent with previously established clinical data. Following treatment initiation, expected adverse events—including decreased appetite, fatigue, somnolence, diarrhea, pyrexia, and nasopharyngitis—were observed more frequently among patients transitioning from placebo. However, investigators reported that the incidence of several commonly observed treatment-emergent adverse events gradually declined during ongoing therapy, suggesting improved tolerability with long-term treatment. Importantly, the analysis did not identify any new safety concerns beyond the known profile of FINTEPLA. Researchers emphasized that the findings should be interpreted within the context of a post hoc analysis, meaning they provide supportive clinical evidence without establishing new efficacy conclusions. Nevertheless, the results strengthen understanding of how patients respond during the critical first months following FINTEPLA initiation and throughout extended treatment.
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New Evidence Supports Improved Management of Rare Epilepsy
Lennox-Gastaut syndrome remains one of the most severe and treatment-resistant developmental epileptic encephalopathies, often beginning in childhood and persisting throughout adult life. Patients experience multiple seizure types, developmental impairment, cognitive challenges, behavioral disorders, and reduced quality of life, while caregivers face significant long-term disease management burdens. According to UCB, the newly published findings help clinicians better understand expected treatment trajectories, including dose titration strategies and the potential benefits of continued therapy. FINTEPLA is currently approved by the U.S. Food and Drug Administration (FDA) for treating seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in patients aged two years and older. The publication further reinforces UCB’s commitment to advancing evidence-based therapies for rare neurological diseases, while supporting physicians with additional clinical data that may help optimize individualized treatment strategies for patients living with difficult-to-control epilepsy.
Source: UCB press release
