Eisai reports positive phase III data for Fycompa

Eisai has published positive new clinical trial data demonstrating the safety and efficacy of its new anti-epileptic drug Fycompa.

Results from the pivotal global trial Study 305 have shown that the once-daily, adjunctive perampanel-based therapy improved seizure control and was acceptably tolerated in subjects with refractory partial-onset seizures.

Meanwhile, interim data from the open-label extension trial known as Study 307 indicates that Fycompa offers an acceptable tolerability profile in patients with refractory partial-onset seizures over the longer term.

The drug was approved by the European Commission last month and is the only EU-licensed therapy to selectively target AMPA receptors, which are thought to play a central role in triggering and maintaining seizures.

Dr Antonio Laurenza, executive director and head of epilepsy at the neuroscience product creation unit of Eisai, said: "These results reinforce perampanel's tolerability profile and demonstrate seizure control over the longer term."

It is estimated that epilepsy affects six million people in Europe, making the introduction of new therapies an important healthcare priority.