1. DIACOMIT® [prescribing information]. Beauvais, France: Biocodex, Inc.; July 2022.
  2. Kassaï B, Chiron C, Augier S, et al. Severe myoclonic epilepsy in infancy: a systematic review and a meta-analysis of individual patient data. Epilepsia. 2008;49(2):343-348.
  3. Wheless JW, Fulton SP, Mudigoudar BD. Dravet syndrome: a review of current management. Pediatr Neurol. 2020; 107:28-40.
  4. European Medicines Agency. EPAR – Scientific Discussion: Diacomit. Published 2007. Accessed November 16, 2020.
  5. Biocodex, Inc., internal documents; 2000.
  6. U.S. Food and Drug Administration. CDER Clinical Review. August 2018.,207223Orig1s000MedR.pdf. Accessed May 12, 2020.
  7. 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.
  8. Chiron C. Stiripentol. Neurotherapeutics. 2007;4(1):123-125.
  9. European Medicines Agency. EPAR summary for the public. Diacomit. Updated June 2014. Accessed November 16, 2020.
  10. U.S. Food and Drug Administration. Search orphan drug designations and approvals. Accessed November 16, 2020.
  11. Pharmaceuticals and Medical Devices Agency. New drugs approved in FY 2012. Accessed November 16, 2020.
  12. Canadian Agency for Drugs and Technologies in Health. Common Drug Review: Clinical Review Report on Diacomit (stiripentol). Accessed November 16, 2020.
  13. Government of Canada. Summary Basis of Decision – Diacomit – Health Canada. Published February 21, 2013. Accessed November 16, 2020.
  14. Australian Department of Health Therapeutic Goods Administration. Australian Public Assessment Report for Stiripentol. Accessed November 16, 2020.
  15. U.S. Food and Drug Administration. Drug Trial Snapshot: DIACOMIT. Accessed November 16, 2020.
  16. Brigo F, Igwe SC, Bragazzi NL. Antiepileptic drugs for the treatment of infants with severe myoclonic epilepsy. Cochrane Database Syst Rev. 2017;5:CD010483.
  17. Villas N, Meskis MA, Goodliffe S. Dravet syndrome: characteristics, comorbidities, and caregiver concerns. Epilepsy Behav. 2017; 74:81-86.
  18. Shmuely S, Sisodiya SM, Gunning WB, Sander JW, Thijs RD. Mortality in Dravet syndrome: a review. Epilepsy Behav. 2016;64(pt A):69-74.
  19. Dravet C. The core Dravet syndrome phenotype. Epilepsia. 2011;52(suppl 2):3-9.
  20. Dravet Syndrome Foundation. What is Dravet syndrome? Accessed November 16, 2020.
  21. 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.
  22. Dravet C. Dravet syndrome history. Dev Med Child Neurol. 2011;53(suppl 2):1-6.
  23. Ohki T, Watanabe K, Negoro T, et al. Severe myoclonic epilepsy in infancy: evolution of seizures. Seizure. 1997;6(3):219-224.
  24. Wu YW, Sullivan J, McDaniel SS, et al. Incidence of Dravet syndrome in a US population. Pediatrics. 2015;136(5): e1310-e1315.
  25. Brunklaus A, Ellis R, Reavey E, Forbes GH, Zuberi SM. Prognostic, clinical and demographic features in SCN1A mutation-positive Dravet syndrome. Brain. 2012;135(pt 8):2329-2336.
  26. Rosander C, Hallböök T. Dravet syndrome in Sweden: a population-based study. Dev Med Child Neurol. 2015;57(7):628-633.
  27. Bayat A, Hjalgrim H, Møller RS. The incidence of SCN1A-related Dravet syndrome in Denmark is 1:22,000: a population-based study from 2004 to 2009. Epilepsia. 2015;56(4):e36-e39.
  28. Surovy M, Soltysova A, Kolnikova M, et al. Novel SCN1A variants in Dravet syndrome and evaluating a wide approach of patient selection. Gen Physiol Biophys. 2016;35:333-342.
  29. NORD (National Organization for Rare Disorders). Dravet syndrome. Accessed November 19, 2020.
  30. Dravet Syndrome Foundation. Could it be Dravet? Accessed November 16, 2020.
  31. U.S. Bioservices; May 1, 2021, to April 30, 2022.
  32. U.S. Food and Drug Administration. Expanded access. Updated March 23, 2021. Accessed July 13, 2022.
  33. National Cancer Institute at the National Institutes of Health. Randomized clinical trial. Accessed July 13, 2022.
  34. National Cancer Institute at the National Institutes of Health. Controlled clinical trial. Accessed July 13, 2022.
  35. DIACOMIT® [medication guide]. Beauvais, France: Biocodex, Inc.; July 2022.
  36. 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.
  37. M, Bleck TP. New anticonvulsant drugs. Focus on flunarizine, fosphenytoin, midazolam and stiripentol. Drugs. 1994 Aug; 48(2): 153-71.
  38. Fisher J. The effects of stiripentol on GABAA receptors. Epilepsia. 2011;52(2):76-78.
  39. Wirrell E, et al. Stiripentol in Dravet syndrome: Results of a retrospective U.S. study. Epilepsia. 2013; 54 (9):1595-1604.
  40. DIACOMIT Periodic Benefit-Risk Evaluation Reports (PBRERs). Beauvais, France: Biocodex, Inc.; January 2022.
  41. Centers for Disease Control and Prevention. Seizure first aid. Accessed August 4, 2022.
  42. Epilepsy Foundation. Seizure observation. Accessed August 4, 2022.
  43. Epilepsy Foundation. Managing your child’s epilepsy. Accessed August 4, 2022.
  44. Centers for Disease Control and Prevention. Types of seizures. Accessed August 4, 2022.
  45. Dravet Syndrome Foundation. Comorbidities in Dravet syndrome. Accessed August 4, 2022.
  46. Dravet Syndrome Foundation. Dravet syndrome in adults. Accessed August 4, 2022.
  47. Covanis, T. Atypical absence seizures. Updated October 18, 2021. Accessed October 5, 2022.
  48. Wylie T, Sandhu DS, Murr N. Status Epilepticus. In: StatPearls. Treasure Island (FL): StatPearls Publishing; May 15, 2022.
  49. Millichap, JJ, Koh, S, Laux, LC, Nordli, DR. Child neurology: Dravet syndrome. When to suspect the diagnosis. Neurology. 2009 Sept; 73:59-62.