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Dravet syndrome: US-approved treatments and how families in the Gulf can access them
A plain guide for families in the Gulf, checked against US FDA labels, US National Institutes of Health information, Gulf drug registers and published research on 17 October 2026.
Reviewed by the Reserve Meds clinical operations team on 17 October 2026.
Dravet syndrome: the short answer
The US FDA has approved three medicines covered on this page for Dravet syndrome, each for a specific group of patients: Fintepla, Diacomit and Epidiolex. On 17 October 2026, three of them were on the Saudi or Abu Dhabi register, so ask your hospital about local supply first. Where a medicine is not registered, the treating hospital can ask the national regulator to import it for one named patient. Reserve Meds is a digital health company that helps with that process. We do not diagnose or prescribe.
- US FDA-approved medicines on this page: Fintepla, Diacomit and Epidiolex.
- Gulf registers (checked 17 October 2026): see each medicine below.
- Legal route: local supply where listed; otherwise a named-patient import request filed by the treating hospital.
- Price: Quote on request.
What is Dravet syndrome?
Dravet syndrome is an epilepsy condition that begins in infancy or early childhood. It belongs to a group of severe epilepsies called developmental and epileptic encephalopathies, which have often drug-resistant seizures and significant developmental delays.[1]
Children with Dravet syndrome have different types of seizures that typically start between 6 and 12 months of age. Most have tonic-clonic seizures, and fevers often come with the seizures. Status epilepticus, a continuous seizure that needs emergency care, can occur.[1]
Several medicines are approved in the US specifically for seizures associated with Dravet syndrome.[2, 3, 4]
Dravet syndrome in the Gulf
A 2025 multicenter study from Saudi Arabia reported on the safety and efficacy of stiripentol in SCN1A-related Dravet syndrome, and Saudi researchers have identified SCN1A mutations in epilepsy patients through whole-exome sequencing (2022).[5, 6]
We checked every medicine on this page against the full SFDA drugs list and the Abu Dhabi Department of Health drug code list on 17 October 2026. 1 of 3 was listed in Saudi Arabia and 3 of 3 in Abu Dhabi. The result for each medicine is shown below. A listing does not mean every hospital stocks the medicine, and federal UAE, Kuwait, Qatar, Bahrain and Oman registers were not checked.[7, 8]
US FDA-approved medicines for Dravet syndrome
Each medicine below is approved in the US for a specific group of patients. The wording summarizes the current US label. Your specialist decides whether any of them is right for the patient.
- Fintepla (fenfluramine)
US FDA-approved for seizures associated with Dravet syndrome and Lennox-Gastaut syndrome in patients 2 years and older. It is an oral solution.[2]
Current US label version: 27 October 2025. Gulf registers: Saudi Arabia (SFDA drugs list): listed. Abu Dhabi (DoH drug code list): listed. Checked 17 October 2026. Federal UAE, Kuwait, Qatar, Bahrain and Oman: not checked; we confirm for your country when you ask.[7, 8]
Country access guides: Saudi Arabia, UAE, Kuwait, Qatar - Diacomit (stiripentol)
US FDA-approved for seizures associated with Dravet syndrome in patients 6 months and older weighing 7 kg or more who are taking clobazam. It is a capsule or powder.[3]
Current US label version: 27 April 2026. Gulf registers: Saudi Arabia (SFDA drugs list): not found. Abu Dhabi (DoH drug code list): listed. Checked 17 October 2026. Federal UAE, Kuwait, Qatar, Bahrain and Oman: not checked; we confirm for your country when you ask.[7, 8]
Country access guides: Saudi Arabia, UAE, Kuwait, Qatar - Epidiolex (cannabidiol)
US FDA-approved for seizures associated with Lennox-Gastaut syndrome, Dravet syndrome or tuberous sclerosis complex in patients 1 year and older. It is an oral solution of cannabidiol, sold as Epidyolex outside the US.[4]
Current US label version: 29 May 2026. Gulf registers: Saudi Arabia (SFDA drugs list): not found. Abu Dhabi (DoH drug code list): listed as Epidyolex. Checked 17 October 2026. Federal UAE, Kuwait, Qatar, Bahrain and Oman: not checked; we confirm for your country when you ask.[7, 8]
How families in the Gulf can access treatment
If the medicine is listed in your country. Ask your specialist and the hospital about local supply first. A listing does not mean every hospital stocks the medicine, but it is usually the fastest route, and you may not need us.
If it is not registered. The usual legal route is a named-patient request: the treating hospital, on your specialist's written request, asks the national regulator for permission to import the medicine for one patient, using the US FDA approval as the reference. In Saudi Arabia the SFDA Special Access Program guidance covers these requests; in Bahrain, NHRA Circular 41 of 2020 sets the procedure. Other Gulf countries have their own procedures, which the hospital confirms.[9, 10] Once approval is in place, Reserve Meds arranges supply through a US-licensed pharmaceutical wholesale partner to the hospital.
Who does what
- Your treating specialist decides whether a medicine is right for the patient and writes the medical letter.
- The hospital checks local supply, files any import request, and gives the treatment safely.
- The national regulator decides whether to approve the import of a medicine that is not registered.
- The manufacturer decides where its medicine can be supplied, especially for cell and gene therapies.
- Reserve Meds helps organize records, coordinates US supply through our wholesale partner, shipping and updates to your family. We do not give medical advice.
Documents you will usually need
- A letter from the treating specialist with the diagnosis, past treatments and why this medicine is being considered
- Reports that confirm the diagnosis, such as genetic, pathology, imaging or laboratory results, translated into English where needed
- Recent clinic notes and a list of current medicines
- For a hospital import request: the prescription, the hospital's request form and the written consent of the patient or guardian
- Proof of the US FDA approval and the US prescribing information (we can supply these)
We give you a written timeline estimate for your case before you commit. The regulator, the hospital or treatment center and the manufacturer set their own timelines.
What treatment costs
Quote on request. Your total cost depends on the medicine, the dose, shipping, import steps and coordination. Your coordination fee is quoted in writing for your case before you commit. No hidden charges.
How Reserve Meds helps
Reserve Meds is a digital health company. Medicines are supplied through a US-licensed pharmaceutical wholesale partner. We help your doctor and hospital prepare the file, arrange US supply and temperature-controlled shipping once approval is in place, and keep your family updated. We coordinate access to FDA-approved medicines only. Investigational medicines are only available through a manufacturer's expanded-access program requested by the treating physician; we can explain that route, but we do not supply them.
Ask us about treatment for Dravet syndrome
Tell us the medicine, your country and a WhatsApp or phone number. We reply within one business day. On WhatsApp we usually reply the same day.
Frequently asked questions
Is there an FDA-approved treatment for Dravet syndrome?
Yes. The medicines on this page have US FDA approval for specific groups of patients: Fintepla, Diacomit and Epidiolex. The exact conditions are in each US label and are summarized above. Your specialist decides whether any of them fits.
Is Fintepla available in Saudi Arabia or the UAE?
We checked on 17 October 2026. Saudi Arabia (SFDA drugs list): listed. Abu Dhabi (Department of Health drug code list): listed. A listing in Abu Dhabi does not show federal UAE status, which we could not verify. Your hospital confirms current supply.
How can a family in the Gulf get Fintepla?
Ask the treating hospital about local supply first. If it is not available, the hospital can file a named-patient import request with the national regulator on your specialist's written request. Once approved, we arrange US supply to the hospital.
How much does treatment cost?
Quote on request. Your total cost, including the medicine, shipping, import steps and coordination, is quoted in writing for your case before you commit. No hidden charges.
Does Reserve Meds diagnose or prescribe?
No. Reserve Meds is a digital health company. Medicines are supplied through a US-licensed pharmaceutical wholesale partner. We do not diagnose, prescribe or decide what a regulator approves. Your specialist and hospital make the medical decisions.
Is Diacomit used on its own?
No. Diacomit's US label is for patients taking clobazam, and the label says there are no clinical data to support its use alone in Dravet syndrome.
Sources for the condition-specific answers: [3]
Sources
Accessed and checked on 17 October 2026. Labels, registers and regulator rules change. Your hospital confirms the current position before anything is filed.
- National Institute of Neurological Disorders and Stroke (NINDS): Dravet Syndrome
- DailyMed: FINTEPLA (fenfluramine) US prescribing information, label version 27 October 2025
- DailyMed: DIACOMIT (stiripentol) US prescribing information, label version 27 April 2026
- DailyMed: EPIDIOLEX (cannabidiol) US prescribing information, label version 29 May 2026
- Almuatiri AM, et al. Stiripentol safety profile and efficacy in cases of SCN1A-related Dravet syndrome, multi-center experience, Saudi Arabia. Neurosciences (Riyadh). 2025 (PubMed 40670066)
- Naseer MI, et al. Whole-Exome Sequencing Identifies Novel SCN1A and CACNB4 Genes Mutations in the Cohort of Saudi Patients With Epilepsy. Front Pediatr. 2022 (PubMed 35813387)
- SFDA: Drugs List, public register (all 9,173 entries checked by brand name on 17 October 2026)
- Department of Health Abu Dhabi: drug code list Drugs.xlsx (release 26 September 2026, effective 2 October 2026)
- SFDA: Special Access Program (SAP) guidance, version 1.0
- NHRA Bahrain: Circular No. (41) of 2020, procedures for importing non-registered medicines and pharmaceutical products
Related
- Lennox-Gastaut syndrome
- Epilepsy
- CDKL5 deficiency disorder
- Fintepla: drug overview
- Diacomit: drug overview
- Named-patient access in the Gulf, explained
- US-approved medicines not yet registered in the Gulf
- Answers to common access questions
- Cross-border disclosures
- اقرأ هذه الصفحة بالعربية
- यह पृष्ठ हिंदी में पढ़ें
This page is general health information, not medical advice. It does not replace a consultation with your doctor.