About DIACOMIT®

DIACOMIT® is an anti-epileptic drug containing stiripentol as the active substance.

DIACOMIT® is to be used as an add-on therapy to Clobazam and Valproate (other anti-epileptic drugs) for Dravet syndrome patients to treat generalised tonic-clonicSeizures during which a tonic phase is succeeded by a clonic phase, with loss of consciousness, still known as 'grand mal'. seizures when these are not adequately controlled with Clobazam and Valproate.

The Dravet syndrome is a rare form of epilepsy since the prevalence is estimated between 1/20,000 and 1/40,000 births. Therefore DIACOMIT® was designated as an ‘orphan medicine’ (a medicine used in rare diseases) on 5th December 2001.

DIACOMIT® was granted a conditional European Marketing Authorisation in 2007 which was switched to full European Marketing Authorisation on January 8th 2014.

In 2012, the Marketing Authorisation was obtained in Canada and Japan.

For children under the age of three, no pivotal clinical studyIs a study which presents the data required by a regulatory agency to decide whether or not to approve a drug. A pivotal study is normally a well-controlled, randomized, of adequate size, and whenever possible, double-blind. has been performed. The clinical decision for administrating DIACOMIT® in children with Dravet syndrome less than 3 years of age needs to be made on an individual patient basis taking into consideration the potential benefits/risks ratio.

For children aged less than twelve months data are limited. For these children the use of DIACOMIT® will be done under the close supervision of medical doctor used to treating epilepsy. Furthermore children from six months of age were included and followed-up in the French companionate programme.

For patients aged 18 and over, long-term data have not been collected in a sufficient number of adults to confirm maintenance of effect in this population. Treatment should be continued for as long as efficacy is observed. 

For references, please access “About DIACOMIT” through the Bibliography part located in Resources tab.

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