Eisai's Fycompa improves seizure control, pivotal Ph III study shows

Japanese drug major Eisai (TYO: 4523) announced results from a pivotal Phase III clinical trial (Study 304) of Fycompa (perampanel), the first in a new class of adjunctive treatment in people with partial-onset seizures, with or without secondary generalized seizures, aged 12 years and older. This showed that once-daily, adjunctive perampanel at doses of 8mg or 12mg improved seizure control in people with uncontrolled partial-onset seizures, and that both doses had an acceptable safety and tolerability profile.

Study 304 is one of three pivotal Phase III studies in the EXPLORE (EXamining Perampanel Observations from Research Experience) clinical trial program and results were published in the August 2012 issue of Neurology, the medical journal of the American Academy of Neurology, published on-line yesterday

The successful treatment of partial-onset seizures (the most common type of epilepsy) remains a challenge in some people. The incidence of uncontrolled epilepsy remains high despite many new anti-epileptic drugs (AEDs) and it is estimated that the proportion of people diagnosed with epilepsy who, are or will become, refractory to treatment range from 20% to as high as 40%.