Expert Interview
Discussing Zogenix’s FINTEPLA for the treatment of seizures associated with LGS: Ahead of the PDUFA set for March 25th
Ticker(s): ZGNX, UCB.XBRUA neurologist with experience in treating Lennox-Gastaut Syndrome associated seizures.
Please describe your clinical practice. How many patients with LGS do you treat on a yearly basis?
Added By: slingshot_insightsCan you tell us more about the standard of care? Have you prescribed cannabidiol(Epidiolex) to your patients? How effective is the treatment in Lennox-Gastaut syndrome?
Added By: slingshot_insightsCould you please discuss the results of Study 1601, that the sNDA is based on, where patients taking FINTEPLA 0.7 mg/kg/day achieved a median reduction of 26.5% compared to a median reduction of 7.8% in patients taking placebo (p=0.0012). Patients taking FINTEPLA 0.7 mg/kg/day demonstrated a 26.5% greater reduction in mean monthly drop seizure frequency compared to placebo (p=0.0034). The median percent reduction in monthly drop seizures between baseline and the treatment period for the lower study dose of FINTEPLA (0.2 mg/kg/day), a secondary endpoint, was 13.2% and did not reach statistical significance compared to placebo (p=0.0915).
The proportion of study patients treated with FINTEPLA 0.7 mg/kg/day who achieved a ≥50% reduction in monthly drop seizures versus placebo. How does it compare to standard of care?
The incidence of patients who experienced at least one adverse event was 89.7% of patients in the FINTEPLA 0.7 mg/kg/day group, 76.4% in the FINTEPLA 0.2 mg/kg/day group and 79.3% in the placebo group. The most common adverse events (≥10%) in the FINTEPLA-treated groups were decreased appetite, somnolence, fatigue, vomiting, diarrhea, and pyrexia. The incidence of serious adverse events was 11.5% (n=10) in the 0.7 mg/kg/day group, 4.5% (n=4) in the 0.2 mg/kg/day group, and 4.6% (n=4) in the placebo group. Six patients in the 0.7 mg/kg/day group had an adverse event leading to study discontinuation compared to four subjects in the 0.2 mg/kg/day group and one patient in the placebo group; the majority of these were considered treatment-related. There was one death during the trial (0.7 mg/kg/day group) caused by SUDEP (sudden unexpected death in epilepsy), which was assessed by the investigator to be unrelated to the study drug.
- Could you tell us your opinion on the Adverse events profile of Fintepla?
Added By: slingshot_insights
How likely would you be prescribe Fintepla to your patients? What are some unmet needs in the space of LGS, and do you think Fintepla can address those?
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