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Diacomit
Published
Product name
Diacomit
Active ingredient
Stiripentol
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Diacomit (stiripentol) was approved for the following therapeutic use:
Diacomit is indicated for adjunctive treatment of generalised tonic-clonic and clonic seizures associated with severe myoclonic epilepsy in infancy (SMEI, also known as Dravet syndrome) in patients whose seizures are not adequately controlled with a benzodiazepine (usually clobazam) and valproate.
How this medicine works
Stiripentol is an antiepileptic medicine intended for the treatment of severe myoclonic epilepsy in infancy (SMEI), also known as Dravet syndrome.The mechanism of antiepileptic activity of stiripentol is based on the potentiation of the gamma-Aminobutyric Acid (GABA)-ergic transmissions in the central nervous system (CNS). In vitro, stiripentol has been shown to directly enhance GABAA receptor-mediated transmission by acting both post-synaptically at a neuronal site coupled to the GABAA receptor and pre-synaptically to increase GABA release from nerve terminals. In rodent models, stiripentol appears to increase brain levels of GABA. This could occur by inhibition of synaptosomal uptake of GABA and/or inhibition of GABA transaminase. Stiripentol has been shown to enhance GABAA receptor-mediated transmission in the immature rat hippocampus and increase the mean open-duration (but not the open frequency) of GABAA receptor chloride channels. Stiripentol also potentiates the efficacy of clobazam and other anticonvulsants, as a result of the pharmacokinetic interactions.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Diacomit was considered favourable for the therapeutic use approved.
Sponsor