The drug is yet to be indicated in any population for the treatment of PGTC
seizures and the phase three study was a post-marketing commitment made by Pfizer to the US Food and Drug Administration (FDA).
In addition, Fycompa has been approved in more than 50 countries, including the United States, Japan, in Europe and in Asia for treatment as an adjunctive therapy for PGTC
seizures in patients with epilepsy 12 years of age and older.
Nearly three quarters (72.2 percent) of those who took Keppra[R] achieved a 50 percent reduction in weekly PGTC
seizures, compared with less than half (45.2 percent) of those in the placebo group (p<0.001).
Trevathan said that "remarkably few randomized control trials have focused on PGTC
seizures exclusively--even though it is one of the more serious forms of epilepsy--and fewer still have focused on children with these seizures," he said.
In the larger study, 117 children, adolescents, and adults with LEG-confirmed PGTC
seizures who were taking one or two concurrent antiepileptic drugs who also experienced three or more PGTC
seizures during an 8-week baseline phase were randomized to adjunctive treatment with lamotrigine (58) or placebo (59).
The sNDA includes data from an ongoing global open-label, multicenter study that evaluated perampanel oral suspension when administered as an adjunctive therapy in children, ages four through 11, with inadequately controlled POS or PGTC
seizures, and also data from an open-label pilot study to evaluate the pharmacokinetics, safety, tolerability, and efficacy of Fycompa oral suspension when given as an adjunctive therapy in pediatric subjects from two to less than 12 years of age with epilepsy.
Based on data accumulated to date, the sNDA also seeks to expand the paediatric indication to include children 2 years of age and older for the adjunctive treatment of PGTC
Additionally, the company's new submission proposes a pediatric indication for adjunctive use for primary generalised tonic-clonic (PGTC
) seizures in patients with epilepsy aged two to less than 12 years.
In addition, Fycompa has been approved in more than 45 countries, including Japan, the United States, and in Europe as an adjunctive therapy for primary generalized tonic-clonic (PGTC
) seizures in patients with epilepsy 12 years of age and older.
The submission also proposes a paediatric indication for monotherapy and adjunctive use for primary generalised tonic-clonic seizures (PGTC
) in children (ages two to less than 12 years) with epilepsy.