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Epilepsy & seizure disorders

Neurologyยท 9 reviewed drugsยท 5119 cited findings behind them

What the regulatory reviews cover

Regulatory review documents in this library cover several drugs for epilepsy and seizure disorders. Briviact is indicated as adjunctive therapy in partial-onset seizures, showing a 32.45% median reduction in POS frequency. Fycompa, for partial-onset seizures, demonstrated a 50% responder rate of 37.6% for perampanel 8 mg versus 26.4% for placebo. Epidyolex, an adjunctive therapy for seizures associated with Lennox-Gastaut syndrome or Dravet syndrome, showed a median percentage change from baseline in total convulsive seizure frequency of -38.94, compared to -13.29 for placebo. Ztalmy, for CDKL5 deficiency disorder, reported a median percent change from baseline in 28-day seizure frequency for major motor seizure types of -29.39 for the treatment group versus -6.49 for placebo.

Fintepla is indicated for seizures associated with Dravet syndrome, showing a 63.9 percent difference in baseline-adjusted CSF reduction. Lacosamide, for neonatal seizures, had a mean (SD) reduction in seizure burden of 6.64 in the lacosamide group. Kigabeq, for infantile spasms and resistant partial epilepsy, showed a Vigabatrin seizure frequency reduction of >= 50% in 33.3% of patients with partial seizures. Perampanel, for partial-onset seizures in patients aged 12 years and older, demonstrated a 50% reduction (responder rate) in seizure frequency of 96.15% in adolescent patients who completed the study. It is important to note that different drugs were studied in different trials, and therefore, the figures presented are not head-to-head comparisons.

The drugs โ€” one cited result each

Briviact

UCB SA

% reduction in POS frequency (median): 32.45

UCB SA โ€” Briviact (in Italy: Nubriveo) EMA EPAR public asses, p.72

Fycompa

Eisai Co., Ltd.

50% responder rate (perampanel 8 mg vs placebo): 37.6% vs 26.4%

Fycompa EMA EPAR public assessment report, p.52

Epidyolex

Jazz Pharmaceuticals plc

Median percentage change from baseline in total convulsive seizure frequency: -38.94

Jazz โ€” Epidyolex EMA EPAR public assessment report (EMEA/H/C, p.109

Ztalmy

Marinus Pharmaceuticals

Median percent change from baseline in 28-day seizure frequency for major motor seizure types (GNX): -29.39

Marinus Emerald โ€” Ztalmy EMA EPAR public assessment report, p.77

Ontozry

Angelini Pharma

Responder rate (>=50% reduction in seizure frequency): 60.4

Angelini S p A โ€” Ontozry EMA EPAR public assessment report (, p.82

Fintepla

UCB SA

Percent difference in baseline-adjusted CSF reduction: 63.9

UCB SA โ€” Fintepla EMA EPAR public assessment report (EMEA/H/, p.54

Lacosamide

UCB SA

Mean (SD) reduction in seizure burden (lacosamide group): 6.64

UCB SA โ€” Lacosamide UCB EMA EPAR variation assessment report, p.7

Kigabeq

Orphelia Pharma

Vigabatrin seizure frequency reduction >= 50% (partial seizures): 33.3

Orphelia S A S โ€” Kigabeq EMA EPAR public assessment report (, p.33

perampanel

Eisai Co., Ltd.

50% reduction (responder rate) in seizure frequency (adolescent, completed study): 96.15%

Eisai Co., Ltd. โ€” Fycompa EMA EPAR variation assessment repo, p.9

Different drugs were studied in different trials โ€” these figures are not head-to-head comparisons.

Explore the full evidence

Every finding behind these drugs โ€” searchable, comparable and answerable in plain language โ€” is in the Neurology research library โ†’

Lists reflect the regulatory review documents in this library, not all therapies that exist. Educational reference only โ€” not medical or investment advice.

Epilepsy & seizure disorders โ€” 9 Drugs, FDA & EMA Review Findings | BioPharmaPT Neurology