Antiepileptic agents: Zonegran in paediatric patients, approved by European Commission


The European Commission ( EC ) has approved extension application regarding the use of antiepileptic agent Zonegran ( Zonisamide ) in the treatment of paediatric patients. The approval extends the use of adjunctive Zonegran in the treatment of partial seizures ( with or without secondary generalization ) by changing the approved age range from adults aged 18 years and above to now also include paediatric patients aged 6 years and above.

Zonegran, an antiepileptic drug, was first approved in March 2005 as an adjunctive therapy for the treatment of partial-onset seizures ( with or without secondary generalization ) in adults with epilepsy and received additional approval in June 2012 as a monotherapy for partial-onset seizures in adults with newly diagnosed epilepsy.

The data used in the application was from a double-blind, randomized, multicenter, placebo-controlled, pivotal phase III study ( Study 312 ) that has evaluated adjunctive Zonisamide in 207 paediatric patients ( 6 to 17 years ) with partial seizures who had received one or two antiepileptic drugs.
The results of the study showed that the proportion of responders ( defined as 50% or greater reduction in seizure frequency ) was significantly higher with Zonisamide versus treatment with placebo.

Study 312 was a double-blind, randomized, multicenter, placebo-controlled study conducted in the European Union and India to evaluate adjunctive Zonisamide in 207 pediatric patients ( 6 to 17 years ) with partial seizures who had received one or two antiepileptic drugs.
Patients were assigned to receive either placebo or Zonisamide for 20 weeks ( 8 weeks of titration, 12 weeks of maintenance therapy ).
The percentage of patients who completed the study was comparable between the Zonisamide and placebo groups ( 86.9% of patients given Zonisamide and 90.0% of patients given placebo ).
Results showed that the proportion of responders ( defined as 50% or greater reduction in seizure frequency ) after the 12-week maintenance treatment, the study’s primary endpoint, was significantly higher with Zonisamide ( 50.5% ) versus treatment with placebo ( 31.0% ).

Safety and tolerability assessments showed that the overall incidence of treatment-emergent adverse events ( TEAEs ) was similar for Zonisamide ( 55.1% ) versus placebo ( 50.0% ).
There were low rates of serious TEAEs in the Zonisamide and placebo groups ( 3.7% versus 2.0% ), and TEAEs leading to withdrawal from the study ( 0.9% versus 3.0% ).
TEAEs reported more frequently with Zonisamide versus placebo were decreased appetite ( 6.5% versus 4.0% ), decreased weight ( 4.7% versus 3.0% ), somnolence ( 4.7% versus 2.0% ), vomiting ( 3.7% versus 2.0% ) and diarrhea ( 3.7% versus 1.0% ). ( Xagena )

Source: Eisai, 2013

XagenaMedicine_2013



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