Recently approved for use in children, age 4 and up, monotherapy or adjunctive treatment with perampanel (Fycompa; Eisai, Woodcliff Lake, NJ) is approved for treatment of partial onset seizures (POS) with or without secondarily generalized seizures. New data show that perampanel can help patients achieve long-term freedom from seizures.
At the recent American Epilepsy Society annual meeting in New Orleans, LA, data from a post hoc analysis, which included patients, age more than 12 years, with secondarily generalized seizures who participated in double-blind studies or open-label extension, showed that of the 80 patients who received perampanel (< 12 mg/day), 53% of patients with secondarily generalized seizures (42/78) had no secondarily generalized seizures for 24 months and 35% (22/63) had no secondarily generalized seizures for 36 months.
For patients with primarily generalized tonic-clonic seizures (PGTC), 21% (35/162) of patients (> 12 years) were seizure free during the double-blind phase of the study. Of those patients, 25 continued in the open-label extension and 84%, 56%, 45.8%, and 31.6% of patients remained PGTC seizure free for 6, 12, 18, and 24 months, respectively. These data suggest that patients treated with perampanel who achieve freedom from seizures can expect that positive effect to last with continued treatment.
In post hoc analysis of pooled data from 4 phase 3 studies, 363 patients who received perampanel 4 mg per day during the trial and the open-label extension (dose of up to 12 mg/day were allowed in the full cohort) still had greater median percent reductions in seizure frequency compared with 616 patients treated with placebo. Increased seizure-free status for both patients with POS (3.6% vs 0.8%) and those with secondarily generalized seizures (18.7% vs 11.1%) also occurred. In this group, the rates of adverse effects were similar to that seen in patients given placebo.
Perampanel was very recently approved by the FDA for use in children, age 4 years and up, with partial onset seizures with or without secondarily generalized seizures. Notably, in a pharmacokinetic analysis, there was no difference found between children and adults in perampanel exposure. In an open-label study of patients with inadequately controlled POS (n = 41; age 4 to <7; n = 120; age 7-12), 50% responder rates were 50% and 41.4% respectively. For patients with PGTC, 50% responder rates were higher in children age 7 to 12 (100%) than in those age 4 to <7 (53.8%). For those with secondarily generalized seizures 50% responder rates were 71.4% (age 7-12) and 50% (age 4 to < 7), although the number of patients age 4 to < 7 with generalized seizures was low (2 with PGTC;14 with secondarily generalized seizures).
For a practicing neurologist, these results are important because the data show that perampanel is effective for patients with any of 3 seizures types, including partial-onset seizures, primarily generalized tonic-clonic seizures or secondarily generalized seizures. Thus, even when it is difficult to determine if a seizure is primarily or secondarily generalized, neurologists can be confident that perampanel will be an effective treatment. Additionally, the efficacy and safety seen in patients given only 4 mg per day suggest that initial dosing of perampanel for patients with new-onset epilepsy could be low and still be effective.Next Story