2023-09-04 13:30:46
Ethypharm’s clobazam oral suspension, to date the only one available for the treatment of epilepsy, has received class A reimbursement from the Italian Medicines Agency (Aifa) as adjunctive therapy for epilepsy in adults and children, a from one month of age, in cases where the standard treatment with one or more anti-seizure medicines has not worked. The treatment of epilepsies in children – explains the pharmaceutical company in a note – is complex due to the great heterogeneity of childhood-onset forms, but also due to the low specificity of the available treatments.
“Clobazam is one of the most prescribed benzodiazepines for the treatment of drug-resistant epilepsies – says Pasquale Striano, director of the Pediatric Neurology and Muscular Diseases Unit, Irccs ‘G. Gaslini’ Institute and professor of Pediatrics Department of Neuroscience, rehabilitation , ophthalmology, genetics and mother-child sciences (Dinogmi), University of Genoa – The oral suspension, now reimbursable, has characteristics that make it a ‘child-friendly’ formulation.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.Another relevant clinical aspect – he adds – is the possibility of modulating the dosage in a more gradual and accurate way, allowing to administer small doses of This characteristic also 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 the other drugs and minimize any adverse events.
There are few anti-seizure drugs recommended by the guidelines that are also authorized in the pediatric age group and with pharmaceutical forms, such as the easy-to-administer oral suspension, that are more suitable for use in this population. Clobazam oral suspension is currently the only medicine to be indicated from one month of age for all types of epileptic seizures, when first-line treatments are ineffective or not tolerated in children, young people and adults.
“Epilepsy – explains Laura Tassi, president of the Italian League against epilepsy (Lice) – is one of the most widespread neurological diseases, with a prevalence of about 1%, which is estimated to affect around 600,000 Italians. Two incidence peaks: the first in pre-school age and the second, growing also considering the increase in the average age of the population, in the elderly and very old.At the basis of the crises – he continues – there may be many causes, so much so that it would be more appropriate talk about epilepsies rather than epilepsy.The type of epilepsy influences the choice of drug therapy, but today, in addition to this, it is increasingly important to also take into consideration other factors such as age, gender, the presence of other diseases and therefore the use of other drugs that can interact with the treatments. Among these, age is particularly important. For example – Tassi recalls – it must be considered that children may have difficulty swallowing the tablet and, especially for them, it is necessary choose a drug, in addition to being effective, also capable of not interfering with cognitive development”.
Despite many advances in the management of people with epilepsy, about 1 in 3 continue to have seizures that are refractory to multiple combinations of antiepileptic drugs. Failure to control seizures – reads the note – has a highly negative impact on patients both from a clinical point of view and from a quality of life. The therapeutic value of clobazam oral suspension as adjunctive therapy in refractory epilepsy has been analyzed in many studies conducted on both adult and pediatric populations, demonstrating its ability to significantly reduce the frequency of epileptic seizures.
“We are very happy – comments Bruno Rago, Vp Head of Cns franchise & General Manager Italy of Ethypharm – to announce the reimbursement of clobazam oral suspension, which finally allows everyone to have the treatment in this new formulation, capable of to better respond to the therapeutic needs of patients of all ages. It is also significant – he concludes – that it can also be prescribed by the general practitioner or the family pediatrician, thus simplifying the path of treatment for patients”.
#Ethypharm #Aifa #reimbursed #antiepileptic #oral #suspension