MedPath
EMA Approval

Diacomit

N03AX17

stiripentol

Antiepileptics

stiripentol

Myoclonic Epilepsy, Juvenile

Basic Information

EMA regulatory identification and product classification information

EMA Identifiers

ATC CodeN03AX17
EMA European Classification

Overview Summary

Comprehensive product overview and regulatory summary

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

Authorisations (1)

EMEA/H/C/000664

Biocodex,22 rue des Aqueducs,94250 Gentilly,France

Authorised

January 3, 2007

Active Substances (1)

stiripentol

Documents (9)

Diacomit : EPAR - Procedural steps taken before authorisation

January 28, 2009

CHANGES_SINCE_INITIAL_AUTHORISATION

Diacomit : EPAR - Scientific Discussion

January 28, 2009

CHANGES_SINCE_INITIAL_AUTHORISATION

Diacomit : EPAR - Scientific Discussion

January 28, 2009

INITIAL_MARKETING_AUTHORISATION_DOCUMENTS

Diacomit : EPAR - Risk-management-plan summary

June 15, 2021

RISK_MANAGEMENT_PLAN_SUMMARY

Diacomit : EPAR - Procedural steps taken before authorisation

January 28, 2009

INITIAL_MARKETING_AUTHORISATION_DOCUMENTS

Diacomit : EPAR - All Authorised presentations

January 28, 2009

AUTHORISED_PRESENTATIONS

Diacomit : EPAR - Summary for the public

January 6, 2009

OVERVIEW_DOCUMENT

Diacomit : EPAR - Product Information

January 3, 2010

DRUG_PRODUCT_INFORMATION

Diacomit : EPAR - Procedural steps taken and scientific information after authorisation

January 3, 2010

CHANGES_SINCE_INITIAL_AUTHORISATION

Overview Q&A (9)

Question

What is Diacomit?

Answer

Diacomit is an anti?epileptic medicine that contains the active substance stiripentol. It is available as capsules and sachets (250 and 500 mg). The sachets contain a powder that is used to make up an oral suspension (a liquid with solid particles in it).

Question

How is Diacomit used?

Answer

Treatment with Diacomit should only be given under the supervision of a doctor who specialises in the diagnosis and management of epilepsy in children (a paediatrician or paediatric neurologist). The recommended dose is 50 mg per kilogram bodyweight, divided into two or three doses during the day. Treatment starts with a dose of 20 mg per kg bodyweight, which is gradually increased to the recommended dose over a number of weeks depending on the patient’s age. After starting Diacomit, the dose of clobazam may need to be reduced. The dose of valproate does not normally need to be adjusted.

The main studies of Diacomit were in children over three years of age. Decisions regarding the use of Diacomit in younger children should be made on a patient-by-patient basis: it can only be given to younger children if the diagnosis of SMEI has been confirmed.

Diacomit should be given at the same time as food, but not with dairy products, carbonated drinks, fruit juice, or food or drinks that contain caffeine or theophylline (a substance found in black and green tea, among other products).

Question

How does Diacomit work?

Answer

The exact way in which stiripentol, the active substance in Diacomit, acts as an anti?epileptic medicine is not fully known. It has been shown in experimental models to increase the levels of a ‘neurotransmitter’ called gamma aminobutyric acid (GABA) in the brain. GABA is the main substance in nerve cells responsible for reducing the electrical activity of the brain. It is also known to amplify the effects of other anti-epileptic medicines and to slow down the rate at which they are broken down by the liver.

Question

What is the risk associated with Diacomit?

Answer

The most common side effects with Diacomit (seen in more than 1 in 10 patients) are loss of appetite, weight loss, insomnia (difficulty sleeping), drowsiness, ataxia (inability to co?ordinate muscle movements), hypotonia (low muscle strength) and dystonia (muscle disorders). For the full list of all side effects reported with Diacomit, see the package leaflet.

Diacomit must not be used in patients who have had psychoses (a serious mental state with a distorted sense of reality) with attacks of delirium (a mental state with confusion, excitement, restlessness and hallucinations). Care must be taken when Diacomit is used at the same time as other medicines. See the package leaflet for the full list of restrictions.

Question

Other information about Diacomit

Answer

The European Commission granted a conditional marketing authorisation valid throughout the European Union for Diacomit on 4 January 2007. This was switched to a full marketing authorisation on 8 January 2014.

For more information about treatment with Diacomit, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Question

What benefit has Diacomit shown during the studies?

Answer

More patients responded to treatment with Diacomit than to placebo. In the first study, 71% of the patients taking Diacomit responded to treatment (15 out of 21), compared with 5% of the placebo group (1 out of 20). Similar results were seen in the second study, with 67% responding to Diacomit (8 out of 12) and 9% to placebo (1 out of 9).

Question

What is Diacomit used for?

Answer

Diacomit is used in children with a very rare type of epilepsy called ‘severe myoclonic epilepsy in infancy’ (SMEI), also known as Dravet’s syndrome. This type of epilepsy first appears in young children during the first year of life. Diacomit is used as an add-on to clobazam and valproate (other anti?epileptic medicines) to treat generalised tonic-clonic seizures (major fits, including loss of consciousness) when these are not adequately controlled with clobazam and valproate.

Because the number of patients with SMEI is low, the disease is considered ‘rare’, and Diacomit was designated as an ‘orphan medicine’ (a medicine used in rare diseases) on 5 December 2001.

The medicine can only be obtained with a prescription.

Question

How has Diacomit been studied?

Answer

Diacomit has been studied in two main studies involving 65 children between three and 18 years of age. The studies compared Diacomit capsules or sachets with placebo (a dummy treatment), when they were added to the children’s existing treatment with clobazam and valproate. The main measure of effectiveness was the number of patients who ‘responded’ to treatment. A patient was classified as a ‘responder’ if the number of seizures in the second month of treatment was at least 50% lower than the number in the month before treatment was started.

Question

Why has Diacomit been approved?

Answer

The CHMP concluded that Diacomit had shown its effectiveness in SMEI, albeit studies were limited and did not last as long as the Committee expected. It decided that Diacomit’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Diacomit was originally given ‘conditional approval’ because there was more evidence to come about the medicine, in particular regarding its short-term and long-term effectiveness and safety. As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full approval.

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Diacomit - EMA Approval | MedPath