Long-Term Freedom from Seizure With Perampanel Treatment

In a post-hoc analysis, of the phase 3 FREEDOM study (NCT03201900), 62.5% of individuals treated with 4 to 8 mg/day of perampanel (Fycompa, Eisai Inc, Woodcliff Lake, NJ) achieved seizure freedom for 1 year. Participants in the study were newly diagnosed or previously untreated individuals with partial-onset seizures (POS), with or without secondarily generalized seizures. Of the 32 participants who began treatment with 4 mg/day of perampanel, 4 (23.5%) had no seizures, but did not  continue treatment. Another 13 (76.5%) experienced at least 1 seizure as follows: SGS, n=6 (35.3%); complex partial seizures (CPS), n=5 (29.4%); simple POS with/without motor signs, n=1 (5.9%) each. These 13 individuals increased their perampanel dose to 8 mg/day. 

In a real-world study of perampanel as an early add-on therapy, seizure freedom rates were 34.8% (n=125/359) and 56.1% (n=32/57) in individuals with focal and generalized seizures. Of participants with focal and generalized seizures, respectively, 34.8% (n=125/359) and 56.1% (n=32/57) achieved seizure freedom. The responder rates in for individuals with focal and generalized seizures were 80.2% and 80.7%, respectively.

The total rate of adverse events was 40.9% (n=174/425), and included behavioral side effects (aggression/anger/irritability; 15.1%), sleepiness (12.9%), and dizziness/vertigo (10.6%). 

"Analyses of real-world data help complement clinical trial evidence by providing information about epilepsy patients with more diverse characteristics than patients typically recruited in trials," said Manoj Malhotra, vice president, head of Medical Affairs for the Neurology Business Group at Eisai and the lead study investigator. "Results from these real-world analyses show the potential of perampanel as a monotherapy and as a first add-on for patients with partial-onset seizures in a routine clinical setting."