Diacomit FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 5, 2023.

FDA Approved: Yes (First approved August 20, 2018)
Brand name: Diacomit
Generic name: stiripentol
Dosage form: Capsules and Powder for Oral Suspension
Company: Biocodex
Treatment for: Dravet Syndrome

Diacomit (stiripentol) is an anticonvulsant for use as an adjunctive treatment with clobazam in Dravet syndrome.

• Diacomit is indicated for the treatment of seizures associated with Dravet syndrome in patients taking clobazam who are 6 months of age and older and weighing 7 kg or more. There are no clinical data to support the use of Diacomit as monotherapy in Dravet syndrome.
• Dravet syndrome is a rare, seizure disorder that usually begins in the first year of life. The seizures can lead to cognitive and physical developmental delays and symptoms may include loss of motor skills, intellectual disability, speech impairment, and difficulty with movement.
• The mechanism of action of Diacomit in the treatment of Dravet syndrome is unclear, but may include direct effects mediated through the gamma-aminobutyric acid (GABA)_A receptor and indirect effects involving inhibition of cytochrome P450 activity with resulting increase in blood levels of clobazam and its active metabolite.
• Diacomit is administered orally, two or three times daily.
• Warnings and precautions associated with Diacomit include somnolence, decreased appetite and decreased weight, neutropenia and thrombocytopenia, risk of increased seizure frequency during withdrawal, risks in patients with phenylketonuria, and suicidal behavior and ideation.
• Common adverse reactions include somnolence, decreased appetite, agitation, ataxia, weight decreased, hypotonia, nausea, tremor, dysarthria, and insomnia.

Development timeline for Diacomit

Further information

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