Eisai Inc. has announced the initiation of two multi-center, global Phase 3 clinical trials assessing FYCOMPA® (perampanel) CIII in two different patient populations: patients age 2 years and above with inadequately controlled seizures associated with Lennox-Gastaut Syndrome (LGS) (Study 338), a rare and often debilitating form of childhood-onset epilepsy, and in children ages 4 through 11 years with inadequately controlled partial-onset seizures (POS) (Study 311).
FYCOMPA is indicated as an adjunctive therapy for the treatment of POS with or without secondarily generalized seizures and primary generalized tonic-clonic seizures in patients with epilepsy who are 12 years of age and older. FYCOMPA is not indicated for LGS, or for patients younger than 12. Please see Important Safety Information for FYCOMPA, including Boxed WARNING for Serious Psychiatric and Behavioral Reactions, below.
"We are committed to helping the epilepsy community through the continued development of options that may address unmet medical needs," said Lynn Kramer, M.D., Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai. "Through the initiation of these two clinical trials – one that looks at the pediatric population and the other involving those with LGS – we hope to demonstrate the value of perampanel for a broader range of patients who suffer from these conditions."
Study 311 is the first pivotal study to follow the November 2015 FDA communication to sponsors that allowed companies "to extrapolate to pediatric patients 4 years of age and older the effectiveness of drugs approved for the treatment of partial-onset seizures (POS) in adults." Under this policy, drug manufacturers must also provide long-term, open-label safety data in patients 4 years and older, the data that Study 311 is designed to provide.