References

  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. https://www.ema.europa.eu/en/documents/scientific-discussion/diacomit-epar-scientific-discussion_en.pdf. Published 2007. Accessed November 16, 2020.
  5. Biocodex, Inc., internal documents; 2000.
  6. U.S. Food and Drug Administration. CDER Clinical Review. August 2018. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/206709Orig1s000,207223Orig1s000MedR.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. https://www.ema.europa.eu/documents/overview/diacomit-epar-summary-public_en.pdf. Updated June 2014. Accessed November 16, 2020.
  10. U.S. Food and Drug Administration. Search orphan drug designations and approvals. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=266108. Accessed November 16, 2020.
  11. Pharmaceuticals and Medical Devices Agency. New drugs approved in FY 2012. https://www.pmda.go.jp/english/review-services/reviews/approved-information/drugs/0002.html. Accessed November 16, 2020.
  12. Canadian Agency for Drugs and Technologies in Health. Common Drug Review: Clinical Review Report on Diacomit (stiripentol). https://www.cadth.ca/sites/default/files/cdr/clinical/sr0360_diacomit_cl_report.pdf. Accessed November 16, 2020.
  13. Government of Canada. Summary Basis of Decision – Diacomit – Health Canada. https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?lang=en&linkID=SBD00181. Published February 21, 2013. Accessed November 16, 2020.
  14. Australian Department of Health Therapeutic Goods Administration. Australian Public Assessment Report for Stiripentol. https://www.tga.gov.au/sites/default/files/auspar-stiripentol-191112.pdf. Accessed November 16, 2020.
  15. U.S. Food and Drug Administration. Drug Trial Snapshot: DIACOMIT. https://www.fda.gov/Drugs/InformationOnDrugs/ucm618455.htm. 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? http://www.dravetfoundation.org/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. https://rarediseases.org/rare-diseases/dravet-syndrome-spectrum/. Accessed November 19, 2020.
  30. Dravet Syndrome Foundation. Could it be Dravet? http://www.dravetfoundation.org/wp-content/uploads/2017/06/Could-it-be-Dravet-brochure-6.14.17.pdf. Accessed November 16, 2020.
  31. U.S. Bioservices; May 1, 2021, to April 30, 2022.
  32. U.S. Food and Drug Administration. Expanded access. https://www.fda.gov/news-events/public-health-focus/expanded-access. Updated March 23, 2021. Accessed July 13, 2022.
  33. National Cancer Institute at the National Institutes of Health. Randomized clinical trial. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/randomized-clinical-trial. Accessed July 13, 2022.
  34. National Cancer Institute at the National Institutes of Health. Controlled clinical trial. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/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. https://www.cdc.gov/epilepsy/about/first-aid.htm. Accessed August 4, 2022.
  42. Epilepsy Foundation. Seizure observation. https://www.epilepsy.com/manage/tracking/observation. Accessed August 4, 2022.
  43. Epilepsy Foundation. Managing your child’s epilepsy. https://www.epilepsy.com/parents-and-caregivers/kids/managing-childs-epilepsy. Accessed August 4, 2022.
  44. Centers for Disease Control and Prevention. Types of seizures. https://www.cdc.gov/epilepsy/about/types-of-seizures.htm. Accessed August 4, 2022.
  45. Dravet Syndrome Foundation. Comorbidities in Dravet syndrome. https://dravetfoundation.org/what-is-dravet-syndrome/comorbidities/. Accessed August 4, 2022.
  46. Dravet Syndrome Foundation. Dravet syndrome in adults. https://dravetfoundation.org/what-is-dravet-syndrome/dravet-adult-resources/. Accessed August 4, 2022.
  47. Covanis, T. Atypical absence seizures. https://www.medlink.com/articles/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.
IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS No contraindications are listed.

WARNINGS & PRECAUTIONSSomnolence DIACOMIT can cause somnolence. Monitor patients for somnolence, particularly when DIACOMIT is used concomitantly with other CNS depressants or clobazam, which is also known to cause somnolence.

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