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Perampanel produces statistically significant reductions in seizure frequency in patients with epilepsy, according to the results of a Phase III study presented on Tuesday at the International Epilepsy Congress in Rome, Italy.
The pivotal study showed that perampanel (8mg, 12mg) produced significant reductions in median seizure frequency (compared to placebo) among patients having patial-onset seizures while receiving treatment with other epilepsy drugs.
The response rates (defined as 50% or greater reduction in seizure frequency) were 14.7% for placebo, 33.3% for 8mg (p=0.002) and 33.9% for 12 mg (p=<0.001).
Study results also showed that perampanel 8 mg once-daily reduced median seizure frequency by 30.5% (p=0.001) and perampanel 12 mg once-daily reduced median seizure frequency by 17.6% (p=0.0011) vs placebo (9.7%) among patients receiving treatment with one to three other epilepsy drugs.
The most commonly reported treatment-emergent adverse events occurring in 10% or more of patients included dizziness, fatigue, headache and somnolence.
Discontinuations due to treatment emergent adverse events were 4.4% for placebo, 9.3% for the 8mg dose of perampanel and 19% for the 12mg dose.
“This third Phase III study demonstrated the statistical and clinical efficacy of perampanel for reducing partial-onset seizures among epilepsy patients,” said Lynn Kramer, President of the Eisai Neuroscience Product Creation Unit.
Perampanel is a highly selective non-competitive AMPA-type glutamate receptor antagonist, developed by Eisai.