WOODCLIFF LAKE, N.J. — A drug under late-stage clinical development by Eisai reduced the frequency of seizures in patients with epilepsy, according to trial results the drug maker presented Tuesday at the 2011 International Epilepsy Congress.
In a 389-patient phase-3 study of the drug perampanel, patients with partial-onset seizures who took the drug in 8-mg and 12-mg doses showed statistically significant reductions in median seizure frequency compared with those who took the placebo while receiving treatment with one to three other epilepsy drugs. The study, dubbed "Study 305," was the third in a phase-3 trial program that enrolled a total of 1,480 patients worldwide.
In the study, 14.7% of patients taking the placebo showed a reduction in seizure frequency by 50% or more, compared with 33.3% of patients taking perampanel in the 8-mg strength and 33.9% of those taking the 12-mg strength. Also, while patients in the placebo group showed a reduction in median seizure frequency of 9.7%, those taking perampanel in the 8-mg strength once per day showed a reduction of 30.5%, while those taking it the 12-mg strength once daily showed a 17.6% reduction.
"This third phase-3 study demonstrated the statistical significance and clinical efficacy of perampanel for reducing partial-onset seizures among epilepsy patients," Eisai Neuroscience Product Creation Unit president Lynn Kramer said. "Eisai is committed to developing new therapies that can offer seizure control and address unmet medical needs, as part of our [human healthcare] corporate mission."