New FINTEPLA® (Fenfluramine) Data Show Long-Term Seizure Frequency Reductions in Patients with Lennox-Gastaut Syndrome (LGS)
- Median reduction in drop seizure frequency was 39.4% at 3 months (n= 227; p<0.0001) and 51.8% for patients assessed over months 10 to 12 (n=170; p<0.0001).
- A Supplemental New Drug Application (sNDA) was recently submitted seeking FDA approval for the use of FINTEPLA in LGS.
"We are excited to report this study analysis on the long-term treatment effect of FINTEPLA for LGS patients in need of relief from the significant burden associated with life-long, treatment-resistant seizures,” said
A total of 247 patients (mean age, 14 years) entered the OLE study after completion of the randomized, controlled portion of Study 1601. An interim analysis was conducted when >90% of patient data were available. The median baseline drop seizure frequency prior to study treatment was 75 per month (range 4 - 2943).
Results presented as of the cut-off date showed patients experienced significant improvements in the frequency of drop seizures in the OLE study. During the treatment period, the median reduction in drop seizure frequency was 39.4% at 3 months (n=227; p<0.0001) and 51.8% for those patients assessed at months 10 to 12 (n=170; p<0.0001). Additionally, of the 170 patients assessed at this timepoint, most (51.2%) responded with a clinically meaningful (≥50%) reduction in drop seizures, while 25.3% of patients demonstrated a profound (≥75%) reduction. Also, 49.2% of investigators and 48.8% caregivers rated their patients as being “much improved” or “very much improved” on the Clinical Global Impression of Improvement (CGI-I) scale.
“We are very pleased with the compelling results of this study analysis demonstrating the potential long-term impact and clinical benefit of FINTEPLA for LGS patients, who face challenges in finding effective seizure control,” said
In the long-term trial, FINTEPLA was generally well tolerated with no observed valvular heart disease or pulmonary hypertension. The most common treatment-emergent adverse events were decreased appetite (n=40, 16.2%), fatigue (n=33, 13.4%), nasopharyngitis (n=31, 12.6%) and seizure (n=27, 10.9%). One patient death occurred; the cause was reported as aspiration pneumonia and was considered unrelated to study drug.
The poster, titled, “FINTEPLA (fenfluramine) provides clinically meaningful reduction in frequency of seizures resulting in a drop in patients with Lennox-Gastaut syndrome for up to 1 year: interim analysis of an open-label extension study,” (
About the OLE Interim Analysis
Patients with LGS who completed a phase 3 randomized clinical trial and were eligible could enroll in the OLE study (NCT03355209). Effectiveness and safety/tolerability were assessed at Months 1, 2, and 3, and thereafter at 3-month intervals. A total of 247 patients had enrolled in the OLE as of
About Lennox-Gastaut Syndrome
Lennox-Gastaut Syndrome (LGS) is a rare and devastating lifelong childhood-onset epilepsy that can arise from multiple different causes. LGS is characterized by many different seizure types, including many that result in frequent falls and injuries and that often don't respond to currently available seizure medications The intellectual and behavioral problems associated with LGS, as well as around-the-clock care requirements, add to the complexity of life with this disease.
Forward Looking Statements
Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “indicates,” “will,” “intends,” “potential,” “suggests,” “assuming,” “designed,” and similar expressions are intended to identify forward-looking statements. These statements include the potential for FINTEPLA to reduce the frequency of seizures and provide clinical benefit to LGS patients, if approved and statements regarding
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Source: Zogenix, Inc