An oral option patients can take both to manage acute attacks and as ongoing prevention
Por décadas, milhões de brasileiros que sofrem de enxaqueca crônica contaram com opções limitadas — analgésicos de amplo espectro ou medicamentos injetáveis de difícil acesso. A aprovação da Anvisa para o Nurtec ODT, da Pfizer, representa uma inflexão nessa trajetória: pela primeira vez, um medicamento oral da classe dos gepantes — projetado para agir na raiz biológica da enxaqueca, e não apenas suprimir a dor — está oficialmente disponível no Brasil. É um avanço que chega não apenas como conquista científica, mas como reconhecimento institucional do peso silencioso que essa condição neurológica impõe à vida cotidiana de quem a carrega.
- A enxaqueca pode durar até 72 horas e incapacitar completamente quem sofre com ela — e até esta semana, as alternativas orais no Brasil eram insuficientes para quem enfrenta quatro ou mais crises por mês.
- O rimegepant age bloqueando a proteína CGRP, responsável pela inflamação e pela sinalização de dor nas crises, oferecendo um mecanismo mais preciso do que os analgésicos convencionais.
- Em ensaio clínico de fase 3 publicado no The Lancet, 21% dos pacientes tratados relataram alívio completo da dor em duas horas, contra 11% no grupo placebo — além de melhora em náuseas, fotofobia e fonofobia.
- Antes da aprovação oficial, alguns pacientes brasileiros já importavam o medicamento com autorização médica; agora, a validade do registro até 2036 abre caminho para acesso ampliado — mas preço e data de comercialização ainda não foram anunciados pela Pfizer.
A Anvisa aprovou nesta semana o Nurtec ODT, medicamento oral da Pfizer indicado tanto para o tratamento agudo quanto para a prevenção de enxaquecas em adultos. A aprovação foi publicada no Diário Oficial na segunda-feira, 25 de maio, e marca a chegada ao Brasil do primeiro gepante oral registrado para essa finalidade.
O princípio ativo, rimegepant, atua bloqueando o CGRP — uma proteína central nos processos de inflamação e dor durante as crises de enxaqueca. Esse mecanismo difere dos analgésicos tradicionais, que atuam de forma mais ampla sem endereçar a origem neurológica da condição. O medicamento é indicado para pacientes que apresentam ao menos quatro episódios mensais, com ou sem aura, e vem em comprimidos de 75 mg.
Os dados clínicos sustentam a aprovação: em estudo publicado no The Lancet, 21% dos participantes que receberam rimegepant relataram alívio completo da dor em duas horas, frente a 11% no grupo placebo. O medicamento também reduziu sintomas associados como náusea, sensibilidade à luz e ao som. Os efeitos adversos foram classificados como incomuns e de baixa gravidade.
A aprovação tem relevância prática imediata: até agora, os medicamentos da mesma classe disponíveis no Brasil exigiam administração injetável. O Nurtec ODT oferece uma alternativa oral acessível tanto para crises agudas quanto como tratamento preventivo contínuo. Alguns pacientes já o utilizavam mediante importação pessoal autorizada por médico.
O registro tem validade até maio de 2036, mas a Pfizer ainda não divulgou preço nem prazo para comercialização no país — uma lacuna que mantém incerta a real acessibilidade do tratamento para a maioria dos pacientes que dele necessitam.
Brazil's health regulator gave the green light this week to Nurtec ODT, an oral medication designed to both treat and prevent migraine attacks in adults. The drug, manufactured by Pfizer, contains rimegepant hemisulfate sesquihydrate—a compound engineered to target the specific biological mechanisms underlying migraines rather than simply masking pain the way traditional painkillers do. The approval was published in the official government gazette on Monday, May 25th.
The medication is intended for adults who experience migraines with or without aura, particularly those dealing with frequent episodes—at least four per month. It comes in 75-milligram tablets packaged in strips of two, eight, or sixteen units. What makes this approval significant is how it expands the available arsenal. Until now, most drugs in this same class available in Brazil required injection. Nurtec ODT offers something different: an oral option that patients can take both to manage acute attacks and as an ongoing preventive treatment.
The drug works by blocking CGRP, a protein involved in inflammation and pain signaling during migraine episodes. This mechanism is more targeted than the broad-spectrum approach of conventional pain relievers. A phase 3 clinical trial published in The Lancet tested the drug's effectiveness in adults experiencing moderate to severe migraine attacks. Participants received either a single 75-milligram dose or a placebo. Within two hours, 21 percent of those given rimegepant reported complete pain relief, compared to 11 percent in the placebo group. Beyond pain reduction, the drug also improved the symptoms patients found most bothersome: nausea, light sensitivity, and sound sensitivity. Thirty-five percent of those treated with rimegepant experienced relief from these accompanying symptoms, versus 27 percent of placebo recipients.
The side effects reported were mild. Nausea and urinary tract infection appeared most frequently, though researchers classified both as uncommon. No serious adverse reactions were identified in the trial data. Migraine itself is a chronic neurological condition that can be profoundly disabling. The pain is often severe, and it frequently comes with nausea, vomiting, and heightened sensitivity to light, smell, and sound. Without treatment, an attack can last anywhere from four to seventy-two hours. Some people experience aura—visual disturbances, sensory changes, or speech difficulties—that arrive minutes before the pain begins.
Rimegepant belongs to a newer class of drugs called gepants, medications developed specifically for migraine management. Other drugs in this category are still awaiting Brazilian approval. Before this official registration, some Brazilian patients had obtained the medication through personal importation with their doctor's authorization. The Anvisa's approval is valid through May 2036. Pfizer has not yet announced pricing or when the drug will become available for purchase in Brazil, leaving many patients who have been managing migraines with limited options still waiting to see whether this new tool will be accessible and affordable.
Notable Quotes
The drug works by blocking CGRP, a protein involved in inflammation and pain signaling, offering a more targeted mechanism than traditional painkillers— Anvisa regulatory assessment
The Hearth Conversation Another angle on the story
Why does an oral version matter so much when injectable options already exist?
Because people take oral medications every day without thinking about it. An injection is a barrier—you need a clinic visit, a trained person to administer it, the psychological weight of a needle. An oral tablet you can carry with you, take at home, use both when a migraine hits and regularly to prevent them. It's the difference between a treatment and a lifestyle.
The trial showed 21 percent pain relief in two hours. That sounds modest.
It is modest compared to what we might hope for. But remember the placebo group hit 11 percent—so the drug is roughly doubling the chance of relief. And it's not just about pain. The nausea, the light sensitivity, the sound sensitivity—those are what actually disable people. A migraine sufferer doesn't just want the headache gone; they want their life back.
Why has this drug been unavailable until now?
It's new. The gepant class itself is recent—drugs designed specifically for migraine rather than repurposed from other conditions. Brazil's approval process takes time. And before official registration, some patients imported it privately, which meant only those with resources and medical connections could access it.
What changes now that it's approved?
Theoretically, it becomes available through normal pharmacy channels. But we don't know the price yet, and that's everything. If it's expensive, approval means little for most people. If it's affordable, it could genuinely shift how millions of Brazilians manage a disease that costs them work days, relationships, quality of life.
Are there other drugs like this coming?
Yes. Other gepants are in the pipeline waiting for Brazilian approval. This is the beginning of a shift in how we treat migraines—moving away from broad painkillers toward drugs that address the actual biology of the disease.