Epilepsy remains one of the most prevalent and challenging neurological conditions, particularly for patients whose seizures persist despite standard therapies. According to the World Health Organization, approximately 50 million people worldwide live with epilepsy. Of these, an estimated 30% experience drug‑resistant epilepsy — a condition in which seizures continue even after appropriate use of at least two anti‑seizure medications.
The clinical manifestations of epilepsy vary widely, from brief lapses of awareness to prolonged motor seizures. Even intermittent episodes can disrupt daily routines, autonomy, safety, education, employment, and social participation.
In 2026, Brazil’s therapeutic landscape for epilepsy is being reshaped with the regulatory approval and introduction of three new medications, expanding options for patients with difficult‑to‑control seizures.
Cenobamate: A New Option for Drug‑Resistant Focal Epilepsy
Brazil’s National Health Surveillance Agency (Anvisa) has approved cenobamate for the treatment of focal seizures in adults with drug‑resistant epilepsy. The medication modulates neuronal excitability to reduce abnormal electrical activity in the brain. In pivotal clinical trials, cenobamate produced a statistically significant reduction in seizure frequency, with a substantial proportion of patients achieving more than 50% reduction in seizure occurrence.
Cenobamate was brought to the Brazilian market by Eurofarma, the first pharmaceutical company to secure registration for the drug in the country. According to Eurofarma’s press release, the compound demonstrated an unprecedented efficacy profile in pivotal studies for drug‑resistant focal epilepsy. The Ministry of Communications highlighted the approval in a March 2026 announcement, underscoring its significance for adult patients who continue to experience seizures despite optimized treatment.
Stiripentol and Fenfluramine: Advancing Care for Dravet Syndrome
For rare and severe pediatric epilepsies, Anvisa has approved stiripentol (brand name Diacomit®) and fenfluramine hydrochloride, both targeting Dravet syndrome — a rare, catastrophic form of childhood epilepsy marked by frequent, prolonged, and treatment‑resistant seizures that often progress to status epilepticus.
Stiripentol is indicated as adjunctive therapy to be used in combination with clobazam and valproate for patients aged six months or older who weigh at least seven kilograms. Dravet syndrome typically emerges in the first year of life in children who previously showed typical development, and rapidly evolves into a complex condition with significant neurological and developmental consequences.
Fenfluramine received regulatory approval in March 2026, following randomized controlled trials that demonstrated meaningful reductions in convulsive seizure frequency among patients with Dravet syndrome. Anvisa’s Collegiate Directorate published the formal resolution outlining the approval and regulatory conditions.
Both stiripentol and fenfluramine function as complementary therapies that enhance the effect of existing anticonvulsants, addressing a critical unmet need in pediatric epilepsy care. Medical publications from the healthcare media outlet Afya emphasize that these approvals expand therapeutic options for a condition historically resistant to conventional treatments.
Market Access and Availability
While Anvisa has granted regulatory approval, commercial availability of Diacomit® awaits price setting by the Câmara de Regulação do Mercado de Medicamentos (CMED) — a mandatory regulatory step before pharmacies can stock the product. Once pricing is defined, the actual rollout will depend on the manufacturer’s distribution strategy. Anvisa has indicated that this transition from approval to market access may take additional weeks or months.
Scientific Community Gathers to Discuss Advances
The timing of these approvals coincides with the 41st Congress of the Brazilian League of Epilepsy (LBE), scheduled for July 15–18, 2026, at the Frei Caneca Convention Center in São Paulo. The four‑day event will convene national and international experts to discuss comprehensive patient care, with dedicated sessions on drug‑resistant epilepsy, epilepsy surgery, advanced diagnostics, clinical neurophysiology, and multidisciplinary management strategies.
Organizers of the LBE congress emphasize that the meeting reinforces the importance of continuous scientific updating in a field that is rapidly evolving with new pharmacological and non‑pharmacological options.
A Growing Arsenal Against a Complex Disease
For the roughly one‑third of epilepsy patients who continue to experience unpredictable seizures — and the associated risks of falls, accidents, and functional limitations — these new approvals represent more than incremental progress. They signal a shift toward mechanism‑specific therapies tailored to distinct epilepsy syndromes, enabling more individualized treatment plans.
Neurologists affiliated with the LBE stress that ongoing follow‑up and discussion of updated therapeutic strategies remain essential. With cenobamate, stiripentol, and fenfluramine now part of Brazil’s therapeutic arsenal, clinicians have additional tools to address some of the most challenging cases — though translating regulatory approval into broad, equitable patient access will require coordinated effort across regulators, payers, and healthcare teams.
As epilepsy care in Brazil advances, the convergence of regulatory innovation, clinical research, and professional education promises tangible gains for millions living with this complex neurological condition.
Source: Olhar Digital
