What is Diacomit?
Diacomit is a medicine that contains the active substance stiripentol. It is available in capsules or in sachets containing (250 and 500 mg). The sachets contain a powder used to make an oral suspension (a liquid containing solid particles).
What is Diacomit used for?
Diacomit is an antiepileptic drug. It is indicated for children with a very rare form of epilepsy called "severe myoclonic epilepsy of" childhood "(EMSI), also known as Dravet syndrome. This type of epilepsy affects young children. Diacomit is indicated as adjunct therapy. to clobazam and valproate (other antiepileptic drugs) in the treatment of tonic-clonic seizures (the most severe seizures, in which loss of consciousness occurs) which cannot be adequately controlled with clobazam and valproate.
Because the number of patients with EMSI is low, the disease is considered 'rare' and Diacomit was designated an 'orphan medicine' (a medicine used in rare diseases) on 5 December 2001.
The medicine can only be obtained with a prescription.
How is Diacomit used?
Diacomit therapy should only be administered under close supervision of a physician experienced in the diagnosis and management of infant and child epilepsy (a pediatrician or pediatric neurologist). The normal dose is 50 mg / kg body weight. divided into two or three doses throughout the day. Treatment usually starts with a reduced dose of the drug, which is gradually increased to the recommended dose over three days. After starting Diacomit therapy it may be necessary to decrease the dose of clobazam. Normally, the dose of valproate does not need to be adjusted.
The main studies involving Diacomit were carried out in children over three years of age. The decision regarding the use of Diacomit in children under the age of three must be made on an individual basis, as appropriate: that is, the drug can only be given to younger children if the diagnosis of EMSI has been confirmed.
Diacomit should be taken with food, but not with milk or dairy products, carbonated drinks, fruit juices or foods and drinks containing caffeine or theophylline (a substance found, for example, in black and green tea).
How does Diacomit work?
The mode of action of the active substance in Diacomit, stiripentol, as an antiepileptic drug is not yet fully known. It is possible that it works by accentuating the activity of other antiepileptic drugs by reducing their rate of metabolism by the liver. It is also possible that it increases the levels of a "neurotransmitter" called gamma-aminobutyric acid (GABA) in the spaces between nerve cells in the brain. Neurotransmitters are substances in the body that transmit signals from one nerve cell to another.
How has Diacomit been studied?
The effects of Diacomit were first tested in experimental models before being studied in humans.
The two main studies involving Diacomit involved 65 children and adolescents between the ages of three and 18. The studies compared the efficacy of Diacomit, in capsules or sachets, with that of placebo (a dummy treatment) in these patients as an add-on to existing clobazam and valproate therapies. The main measure of efficacy was the number of patients "reactive" to treatment. A patient was defined as "reactive" if the number of seizures in the second month of treatment had decreased by at least 50% compared to that of the month preceding the start of therapy.
What benefit has Diacomit shown during the studies?
The number of patients reactive to Diacomit was higher than that of patients treated with placebo. In the first study, 71% of patients taking Diacomit were responsive to treatment (15 out of 21), compared with 5% in the placebo group (1 out of 20). Similar results were also seen in the second study with 67% of patients reactive to Diacomit (8 out of 12), compared to 9% in the placebo group (1 out of 9). However, it is unclear whether this effect is due to Diacomit or the increased levels of the other antiepileptic drugs.
What is the risk associated with Diacomit?
The most common side effects seen with Diacomit (more than 1 in 10 patients) are anorexia (loss of appetite), weight loss, insomnia, somnolence, ataxia (inability to coordinate muscle movements), hypotonia (muscle weakness) and dystonia ( muscles). For the full list of side effects reported with Diacomit, see the Package Leaflet.
Diacomit must not be used in people who are hypersensitive (allergic) to stiripentol or any of the other ingredients. It should also not be used in patients who have a history of psychosis (severe mental state involving an altered sense of reality) and with delusional episodes (mental state characterized by confusion, excitement, restlessness and hallucinations). Particular caution should be exercised when Diacomit is administered concomitantly with other medicinal products. For the complete list of these medicines, see the Package Leaflet.
Why has Diacomit been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that Diacomit has been shown to be effective in the treatment of EMSI, although the number of studies is small and their duration shorter than that foreseen by the Committee. The Committee decided that the Diacomit's benefits are greater than its risks for use in combination with clobazam and valproate in adjunctive therapy of refractory generalized tonic-clonic seizures in patients with severe childhood myoclonic epilepsy, EMSI (or Dravet syndrome) in whom seizures do not are adequately controlled with clobazam and valproate, and the committee therefore recommended that Diacomit be given a marketing authorization.
Diacomit has obtained "conditional approval". This means that further data on the drug are awaited. Each year, the European Medicines Agency (EMEA) will review any new information that becomes available and, if necessary, update this summary.
What information is still awaited for Diacomit?
The company that makes Diacomit will conduct a study comparing Diacomit with clobazam, as add-on therapy in the ongoing treatment of patients whose symptoms are not adequately controlled with clobazam and valproate.
What measures are being taken to ensure the safe use of Diacomit?
The company that makes Diacomit will monitor the effects of the drug on the stomach and intestines and on growth rate, particularly if taken concomitantly with valproate. It will also look at the effects of taking Diacomit together with other drugs. the risk of long-term problems affecting the brain and nervous system.
Other information about Diacomit:
On 4 January 2007, the European Commission granted Biocodex a "marketing authorization" for Diacomit, valid throughout the European Union.
For the summary of the opinion of the Committee for Orphan Medicinal Products in relation to Diacomit click here.
For the full version of Diacomit's EPAR click here.
Last update of this summary: 12-2008.
The information on Diacomit - stiripentolo published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
