DIACOMIT® (stiripentol) is

FIRST and PROVEN

For seizures associated with Dravet syndrome

The FIRST Dravet-specific antiseizure medication:

With nearly 3 decades of real-world experience In over 55 countries1-5

FDA approved for children as young as 6 months6

Weighing 15 lb or more and taking clobazam

A PROVEN, effective treatment that can:

Significantly reduce seizures associated with Dravet syndrome

It is clinically proven to control generalized clonic and tonic-clonic seizures6

Help patients achieve seizure freedom

Nearly 39% of patients were seizure-free during a two-month study period6,7

Proven Results for Your Patients With Dravet

DIACOMIT established efficacy and safety in two double-blind, placebo-controlled pivotal trials with an open-label extension.6,7

Review the Data

DIACOMIT has more than 69,000 patient-years of experience5

Biocodex, a pioneer in Dravet syndrome treatment, develops stiripentol

FDA approves stiripentol for compassionate use in the United States

DIACOMIT is approved in the European Union

Stiripentol is officially FDA approved and now known as DIACOMIT

FDA expands the indication to include patients as young as 6 months

Early Intervention Matters

  • Frequent and prolonged seizures can contribute to several medical and developmental issues, including a higher risk for sudden unexpected death in epilepsy (SUDEP)8-12
  • Patients with Dravet have a 49% increased risk for SUDEP, which may be associated with tonic-clonic seizure frequency13

Since seizures associated with Dravet may not respond to the standard antiseizure medications (ASMs), it is crucial to determine the right ASM combination for each patient. It is common to treat with multiple ASMs, including others indicated for Dravet.*14

*Clinical discretion is advised when managing ASM regimens

Recommended as a first- or second-line treatment by an international panel of experts14

“The demonstrated efficacy of these ‘DS-specific’ medications strongly supports their use earlier in the treatment paradigm… We should redefine our expectations of seizure control, and no longer accept seizures every 1 to 2 months as the best we can do.”

International Consensus on Diagnosis and Management of Dravet Syndrome (2022)

Results with DIACOMIT may vary

1. Chiron C, Marchand MC, Tran A, et al; for the STICLO study group. Stiripentol in severe myoclonic epilepsy in infancy: a randomised placebo-controlled syndrome dedicated trial. Lancet. 2000;356(9242):1638-1642. 2. Farwell JR, Anderson GD, Kerr BM, Tor JA, Levy RH. Stiripentol in atypical absence seizures in children: an open trial. Epilepsia. 1993 Mar-Apr;34(2):305-11. 3. Bebin M, Bleck TP. New anticonvulsant drugs. Focus on flunarizine, fosphenytoin, midazolam and stiripentol. Drugs. 1994 Aug;48(2):153-71. 4. Perez J, Chiron C, Musial C, Rey E, Blehaut H, d’Athis P, Vincent J, Dulac O. Stiripentol: Efficacy and tolerability in children with epilepsy. Epilepsia. 1999;40(11):1618-1626. 5. Periodic Benefit-Risk Evaluation Report for Active Substance Stiripentol from November 2022 to November 2023. 6. DIACOMIT® [prescribing information]. Beauvais, France: Biocodex, Inc.; July 2022. 7. U.S. Food and Drug Administration. CDER Clinical Review. August 2018. https://www.accessdata.fda.gov/drugsatfda_docs nda/2018/206709Orig1s000,207223Orig1s 000MedR.pdf. Accessed May 12, 2020. 8. Wheless JW, Fulton SP, Mudigoudar BD. Dravet syndrome: a review of current management. Pediatr Neurol. 2020;107:28-40. 9. Dravet Syndrome Foundation. What is Dravet syndrome? http://www.dravetfoundation.org/what-is-dravet-syndrome. Accessed November 16, 2020. 10. Wirrell EC, Laux L, Donner E, et al. Optimizing the diagnosis and management of Dravet syndrome: recommendations from a North American consensus panel. Pediatr Neurol. 2017;68:18-24. 11. Sveinsson O, Andersson T, Mattsson P, Carlsson S, Tomson T. Clinical risk factors in SUDEP: A nationwide population-based case-control study. Neurology. 2020;94(4):e419-e429. 12. Zhao H, Long L, Xiao B. Advances in sudden unexpected death in epilepsy. Acta Neurol Scand. 2022;146:716-722. 13. Shmuely S, Sisodiya SM, Gunning WB, Sander JW, Thijs RD. Mortality in Dravet syndrome: A review. Epilepsy Behav. 2016;64(Pt A):69-74. 14. Wirrell EC, Hood V, Knupp KG, Meskis MA, Nabbout R, Scheffer IE, Wilmshurt J, Sullivan J. International consensus on diagnosis and management of Dravet syndrome. Epilepsia. 2022;63(7):1761-1777.