DIACOMIT® is an original anti-epileptic drug resulting from BIOCODEX’s research programme. Its chemical structure is not related to any other known anticonvulsant and its active substance is stiripentol.
DIACOMIT® was designated as an orphan drug by the European Medicines Agency (EMA) on December 5th 2001 for its use in Severe Myoclonic Epilepsy in Infancy (SMEI).
On January 8th 2014, the conditional approval originally given to DIACOMIT® was switched to full European Marketing Authorisation for use in conjunction with valproate and clobazam as adjunctive therapy of refractory generalized tonic-clonic seizures in patients with Severe Myoclonic Epilepsy in Infancy (SMEI, Dravet’s syndrome) whose seizures are not adequately controlled with clobazam and valproate.
On September 28th 2012, The Marketing Authorisation was granted for Japan.
On December 21st 2012 it was granted for Canada.
When used according to the marketing authorisation, DIACOMIT®‘s benefits / risks profile is considered as favourable by the European Medicine Agency (EMA)’s Committee for Medicinal Products for Human Use, by Health Canada’s(HC-SC) review and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.
DIACOMIT® is the only antiepileptic drug to have clinically shown its efficacy in Dravet syndrome patients by two double blind placebo controlled trials.
DIACOMIT® is available in dosage of 250mg and 500mg, both in hard capsules and powder for oral suspension in sachets.
DIACOMIT® treatment should be undertaken under the supervision of a medical doctor who is knowledgeable about Dravet Syndrome. All initiation, change or modification of antiepileptic treatment must only be made with the approval of the medical practitioner who regularly follows the patient. If you should have any questions regarding treatments, you should feel free to ask this doctor.
For references, please go to the Bibliography part available in the HOME resources tab