Clobazam, the “child-friendly” antiepileptic drug that is now reimbursable
Thanks also to its formulation in oral suspension, clobazam from the French company Ethypharm is the only drug to be indicated from one month of age for all types of epileptic seizures, when first-line treatments are ineffective or not tolerated. All the details
There are few drugs for the treatment of epilepsy, especially in children, but one of these – clobazam in oral suspension by Ethypharm – has received the green light from the Italian Medicines Agency (Aifa) for reimbursement.
It is the only medicine to be indicated from one month of age for all types of seizures when first-line treatments are ineffective or not tolerated in children, young people and adults.
Furthermore, underlined Bruno Rago, Vp Head of Cns franchise & General Manager Italy of Ethypharm, the drug can now also be prescribed by the general practitioner or family pediatrician, "thus simplifying the patient care path".
A “CHILD-FRIENDLY” FORMULATION
"Clobazam is one of the most prescribed benzodiazepines for the treatment of drug-resistant epilepsies", Pasquale Striano, director of the Pediatric Neurology and Muscular Diseases Unit, Irccs Istituto G. Gaslini and professor of Pediatrics Department of Neurosciences, explained to Askanews , rehabilitation, ophthalmology, genetics and mother-child sciences (Dinogmi), University of Genoa.
Furthermore, the news of the reimbursability of clobazam in oral suspension by Ethypharm is important because the treatment of epilepsies in children is complex due to the great heterogeneity of infantile-onset forms but also due to the low specificity of the available treatments. And its formulation in oral suspension is easy to administer and, therefore, more suitable for children.
“The oral suspension, now reimbursable – added Striano -, has characteristics that make it a formulation 'suitable for children'. First of all, compared to the tablet or capsule forms, it is easily assimilated making it appropriate for the little ones and, in general, for all those patients with difficulty swallowing".
Not only. “Another relevant clinical aspect – continues the expert – is the possibility of modulating the dosage more gradually and accurately, allowing the administration of small doses of clobazam. Also this feature allows, on the one hand, to be able to administer the drug to pediatric patients, who generally require lower doses, and on the other to be able to proceed with a much more gradual dosage titration, which can limit the potential interaction with other drugs and minimize any adverse events.
DATA ON EPILEPSY IN ITALY
“Epilepsy is one of the most widespread neurological diseases, with a prevalence of about 1%, which is estimated to affect around 600,000 Italians”. This was reported by Laura Tassi, president of the Italian League against epilepsy (Lice), who also recalled that two peaks of incidence are observed: "the first in pre-school age and the second, growing also considering the increase in age average of the population, in the elderly and very elderly".
“Despite many advances in the management of people with epilepsy, approximately 1 in 3 continue to have seizures that are refractory to multiple combinations of antiepileptic drugs. Failure to control seizures – reads the note from the pharmaceutical company reported by Askanews – has a strongly negative impact on patients both from a clinical point of view and from a quality of life”.
But according to reports from Ethypharm, clobazam oral suspension has been shown to be able to significantly reduce the frequency of epileptic seizures in many studies conducted on both adult and pediatric populations.
ONE DISEASE, MANY FORMS
However, for Tassi it would be more appropriate to speak of "epilepsy" rather than the disease in the singular because "there can be many causes at the base of the seizures".
An aspect which, together with other factors such as age, gender, the presence of other diseases and therefore the use of other drugs that can interact with treatments, determines the choice of drug therapy. And it is precisely age, underlines Tassi, that is particularly important: "For example, we must consider that children may have difficulty swallowing tablets and, especially for them, it is necessary to choose a drug that is not only effective, but also capable of not interfering with cognitive development.
WHAT ETHYPHARM DOES
Ethypharm is a French pharmaceutical company founded in 1977 and specialized in medicines for the central nervous system and intensive care. Between its offices in Europe – France, Spain, Germany, Italy, the United Kingdom – and China it has around 1,500 employees.
It landed in our country in 2021 with an operational headquarters in Padua, under the leadership of Rago, and serves two pharmaceutical channels: hospital and retail.
Direct sales in Europe, reports Ethypharm, represent 49% of the group's net turnover, which in 2021 was 359 million euros.
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/clobazam-il-farmaco-antiepilettico-a-misura-di-bambino-che-ora-e-rimborsabile/ on Tue, 05 Sep 2023 11:31:55 +0000.