New FYCOMPA data presented at ECE
This data was proven in the safety profile of Study 332. The poster presented at ECE featured the results of the Phase 3 study, which was open-label, randomized, double-blind and placebo-controlled.
"The extension study shows that patients with primary generalized tonic clonic seizures in idiopathic generalized epilepsy achieve similar clinical benefits, with consistent tolerability, to those seen previously in Study 332," Paracelsus Medical University Professor and Chair of the Department of Neurology Eugen Trinka said.
FYCOMPA has been indicated in the U.S. for the treatment of partial-onset seizures (POS) in patients who have epilepsy and are 12 years of age and older.
During the FYCOMPA trial, 138 patients were given adjunctive perampanel once a day for the span of 136 weeks. This followed a period of six weeks during which the doses were optimized during blinded conversion.