Results presented today of a Phase III pivotal study for the investigational compound perampanel for partial-onset seizures showed that perampanel, 8 mg and 12 mg, produced statistically significant reductions in median seizure frequency compared to placebo among patients having partial-onset seizures while receiving treatment with one to three other epilepsy drugs. The results were presented at the 2011 International Epilepsy Congress. Perampanel is a highly selective non-competitive AMPA-type glutamate receptor antagonist discovered and being developed by Eisai.
In Study 305, the response rates (defined as 50 percent or greater reduction in seizure frequency) were 14.7 percent for placebo, 33.3 percent for 8mg (p=0.002) and 33.9 percent for 12 mg (p=<0.001). Study results also showed that perampanel 8 mg once-daily reduced median seizure frequency by 30.5 percent (p=0.001) and perampanel 12 mg once-daily reduced median seizure frequency by 17.6 percent (p=0.0011) vs placebo (9.7 percent) among patients receiving treatment with one to three other epilepsy drugs. The most commonly reported treatment-emergent adverse events occurring in Study 305 in 10 percent or more of patients included dizziness, fatigue, headache and somnolence. Discontinuations due to treatment emergent adverse events were 4.4 percent for placebo, 9.3 percent for the 8mg dose of perampanel, and 19 percent for the 12mg dose of perampanel.
"This third Phase III study demonstrated the statistical and clinical efficacy of perampanel for reducing partial-onset seizures among epilepsy patients," said Lynn D. Kramer, MD, FAAN, President, Eisai Neuroscience Product Creation Unit. "Eisai is committed to developing new therapies that can offer seizure control and address unmet medical needs, as part of our hhc (human health care ) corporate mission."
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