Eisai recently presented data in Boston showing that the effect of its epilepsy treatment, Fycompa, and other antiepileptic drugs (AEDs) against primary generalized tonic-clonic seizures seems to be similarly positive in children and adults.
The company’s presentation at the annual meeting of the American Academy of Neurology, held April 22-28, also covered Fycompa’s interaction with Tegretol (carbamazepine), which reduces Fycompa’s concentration in the blood.
The abstract was titled “Extrapolation of Efficacy Data from Adults with Primary Generalized Tonic-clonic Seizures (PGTC) to Pediatric Patients: A Meta-analysis of Published Clinical Trials.”
Primary generalized tonic-clonic seizures (PGTC) are a form of seizure characterized by violent convulsions that involve the entire body and loss of consciousness. The episodes usually last from one to three minutes. If they last more than five minutes, they’re considered a medical emergency.
Children who have these seizures are among the patients who might benefit from Fycompa, Eisai says. Fycompa is approved to be used in combination with other AEDs to treat partial seizures and PGTCS in epilepsy patients who are age 12 and older.
Eisai researchers conducted a review of published studies that evaluated the use of antiepileptic drugs to treat PGTC seizures. The seven studies included in the meta-analysis assessed the drugs’ ability to reduce seizure frequency and the percentage of people whose seizures were reduced by 50 percent or more.
The seven studies included two clinical trials conducted in adults, one trial in adolescent and pediatric patients with PGTC seizures, two studies in adolescents and adults, and two studies in adults and adolescents.
One of the studies included in the meta-analysis was a Phase 3 clinical trial (NCT01393743) that tested the safety and effectiveness of Fycompa as an adjunctive therapy in patients with epilepsy age 12 and older with PGTC.
The researchers found that the treatments were equally as effective in adults and children age 4 and older with PGTC seizures.
“Given that conducting clinical trials in children with epilepsy is challenging, it is important to explore the value of extrapolating clinical trial data from adult to pediatric patients ages 4 and older,” Lynn Kramer, MD, chief clinical officer and chief medical officer at Eisai, said in a recent news release.
“We are glad that, based on this meta-analysis, adjunctive AED treatment appears to be similar in adults and children with PGTC seizures and its effect was not dependent on age,” he said.
