PracticeUpdate Conference Series - ANZAN 2018

Perampanel Demonstrates Sustained Long-Term Efficacy Against Secondarily Generalized Seizures and Safety in Idiopathic Generalized Epilepsy Perampanel has been found to demonstrate good and sustained long-term efficacy against secondarily generalized seizures, finds a pooled analysis of phase III studies and their open-label extension.

D avid Ko, MD, of Loma Linda University in California, explained that perampanel is approved for adjunctive treatment of partial seizures, with or without secondarily generalized seizures and primary generalized tonic-clonic sei- zures in patients with epilepsy age ≥12 years. “Generalized seizures,” Dr. Ko told Elsevier’s PracticeUpdate , “either primary/idiopathic or sec- ondarily generalized – now called bilateral to tonic clonic – are very dramatic seizures with potentially serious consequences including sudden unex- pected death in epilepsy patients (SUDEP).” He continued, “Most studies for partial seizures (now called focal seizures) report a reduction in these but few address secondarily generalized seizures, formerly called gran mal seizures. “Perampanel has been approved as monotherapy for partial seizures,” Dr. Ko noted. “More informa- tion on using it can be gleaned from analyzing reports of with non-enzyme-inducing antiepileptic drugs. The long half-life of perampanel of 106 h

needs to be considered when determining the optimal use of this antiepileptic drug with a novel mechanism of action.” The approval of perampanel for partial seizures was based on results of three randomized, double- blind, placebo-controlled, phase III studies: 304, 305, and 306. Patients completing any of these were eligible to enter the open-label extension of study 307. Dr. Ko and colleagues set out to report on the efficacy of perampanel as adjunctive treatment of secondarily generalized seizures. Enzyme-inducing antiepileptic drugs vs non-enzyme-inducing antie- pileptic drugs were administered in both the phase III and open-label extension studies. In the double-blind studies, patients (≥12 years of age) with partial seizures with or without second- arily generalized seizures, who were receiving one to three antiepileptic drugs at baseline were randomized to placebo or 2–12 mg perampanel daily for 19 weeks. In the open-label extension, patients received perampanel ≤12 mg daily for ≤272 weeks. Efficacy assessments included median percent change in the frequency of secondarily generalized seizures in 28 days, and 50% and 75% responder and seizure-freedom rates, respectively. For patients with secondarily generalized seizures at baseline prior to receiving perampanel, 564

" …non-enzyme-inducing antiepileptic drugs data may be more relevant to

consider when perampanel is used as a single agent (no other enzyme-inducing antiepileptic drug) while real-world data and experience are accumulated. "

PRACTICEUPDATE CONFERENCE SERIES • ANZAN 2018 16