Epilepsy has a high prevalence and impacts 0.5% to 1% of the paediatric population. In the UK there are an estimated 60,000 children under the age of 18 with epilepsy. The estimated number of children and adolescents in Europe with active epilepsy is 0.9 million. With extemporaneous preparations of paediatric formulations of antiepileptic drugs (AED), the amount of active ingredient received by the patient can vary as much as 20%. A 10% decrease in AED concentration is sufficient to cause a previously seizure-free patient to suffer breakthrough seizures, with consequences such as emotional distress, injury or even death. Increased hospitalisation, doctor visits and need for more medication add to the societal burden. The European Medicines Agency (EMA) has highlighted increased research into paediatric drugs for epilepsy as a priority need. A Spanish study estimated the mean cost per child with epilepsy as $1,853 for controlled and $4,950 for uncontrolled epilepsy.
Proveca are developing new paediatric appropriate formulations of AEDs.