Several abstracts from Eisai on its epilepsy treatments Fycompa (perampanel) and rufinamide (marketed as Inovelon in Europe and Banzel in the U.S.) were recently presented at this year’s 12th European Congress on Epileptology (ECE). The data provided further evidence as to the efficacy and safety of both drugs in different types of epilepsy seizure, including generalized tonic clonic seizures (primary and secondary) and Lennox-Gastaut syndrome.
Fycompa is approved in both the U.S. and the European Union to be used in addition to other drugs to treat partial onset seizures and generalized tonic-clonic seizures in people older than 12 years.
Inovelon/Banzel is an anticonvulsant medication approved in the U.S. and the E.U. as an adjunctive treatment with other medication and therapy for seizures associated with Lennox-Gastaut syndrome in children 4 years and older, and in adults.
“The data presented at ECE reinforce Eisai’s continued focus on epilepsy treatment options that have the potential to improve outcomes in different patient populations. Epilepsy is a challenging condition to manage — those affected by it just want to get on with life through better seizure control and acceptable tolerability. Building the evidence for perampanel and rufinamide is therefore vital to enable clinicians to better understand and optimise treatment outcomes in clinical practice,” Neil West, Vice President, Global Neurology Business Group, Eisai EMEA, said in a press release.
During the congress, findings from data analyses of a Phase 3 study (NCT01393743) were presented. Additionally, data from an interventional open label extension of the study, and a post-hoc analyses in myoclonic and absence seizures was also presented.
The trial, referred to by Eisai as Study 332, was a double-blind, randomized, placebo-controlled, multicenter, and parallel-group trial assessing the safety and the efficacy of adjunctive Fycompa for refractory primary generalized tonic-clonic (PGTC) seizures in patients with idiopathic generalized epilepsy (IGE). A total of 164 patients, over 12 years old and with PGTC seizures and IGE despite treatment with one to three concomitant AEDs, were randomly assigned to receive Fycompa (8 mg/d or highest tolerated dose) or placebo.
According to a report on the trial’s results, published in 2015 in the journal Neurology, 30.9% of the Fycompa-treated patients achieved PGTC seizure freedom, compared to the 12.3% receiving placebo. Seizure frequency and seizure responder rate also improved with the drug. Regarding the drug’s safety, the most frequent adverse events reported were dizziness and fatigue, which ocurred in 32.1% and 14.8% of the Fycompa-treated patients, respectively.
More information about the abstracts presented, which relate to several other studies on Fycompa, Inovelon/Banzel, and other epileptic drugs, at the ECE, (held in Prague, Czech Republic, Sept. 11–15), can be found here.
Lennox-Gastaut syndrome (LGS) is a type of epilepsy with multiple different types of seizures, particularly tonic (stiffening) and atonic (drop) seizures. Intellectual development is usually, but not always, impaired.