New drugs, treatments, studies and clinical guidelines, summarised in plain language with a link to the original source.
New drugs
The FDA approves the first oral agent of its class for adults with migraine
The FDA approved lasmiditan (Reyvow), the first 5-HT1F receptor agonist for the acute treatment of migraine with or without aura in adults. Based on two phase 3 trials with 3,177 patients, the drug proved to be significantly superior to placebo in eliminating pain and the most bothersome symptom at 2 hours. For the patient, it represents a new oral therapeutic option, although it requires caution due to side effects such as dizziness and sedation, prohibiting driving or operating machinery for 8 hours after taking it.
Tolerability, safety, and efficacy of atogepant versus topiramate in adults with migraine (TEMPLE): a randomized, head-to-head, phase 3b trial
This phase 3b clinical trial compared atogepant against topiramate in 540 adults with migraine from 12 countries. The results showed that atogepant is better tolerated: only 12% discontinued treatment due to adverse effects compared to 30% with topiramate. Additionally, 64% of patients on atogepant reduced their migraine days by half, compared to 39% in the topiramate group. For the patient, this means a more effective oral preventive option with fewer side effects that make it easier to follow the treatment in the long term.
Weight loss with atogepant in the long-term treatment of migraine: An interim analysis of a safety endpoint from a 156-week, open-label, multicenter phase 3 extension study
This interim analysis of a phase 3 study evaluated 595 patients with episodic and chronic migraine in the USA and other centers who used 60 mg daily of atogepant. After 52 weeks, a mean weight reduction of 2.16 kg was observed, and 29.5% of participants achieved clinically significant weight loss (≥5%). For the patient, this suggests that preventive treatment with atogepant is not only safe in the long term but could also favor weight reduction, especially in people with a high body mass index.
The European Commission has authorized the use of atogepant, a drug from the gepants class, for the acute treatment of migraine with or without aura in adults. Based on the 'Eclipse' study, the drug managed to eliminate pain in the majority of patients starting from 90 minutes and for up to 48 hours. This change is key for those who do not respond to other treatments, allowing the oral use of a drug that was previously only used as a preventive.
FDA grants De Novo authorization to Avulux lenses for migraine photophobia
The FDA authorized Avulux optical filter lenses to reduce the impact of light sensitivity in patients aged 12 and older with episodic migraine. This over-the-counter device blocks specific wavelengths (480 nm and 590 nm) without replacing acute or preventive treatments. The decision was based on randomized studies and real-world data, although the announcement did not detail efficacy or safety figures. For the patient, it represents a non-invasive and regulator-recognized option to manage photophobia as a complementary symptom.
The Canadian Drug Agency recommends reimbursement of UBRELVY® (ubrogepant) for the treatment of migraine attacks
The Canadian Drug Agency has issued a positive recommendation for the public reimbursement of UBRELVY (ubrogepant), an oral CGRP antagonist drug for adults with migraine with or without aura. The decision is based on phase III studies that demonstrated efficacy in the suppression and relief of pain and associated symptoms. This advancement in Canada expands specific therapeutic options for attacks, allowing for greater treatment personalization and improving access for patients with moderate to high intensity headaches.
The US FDA approves an over-the-counter Tylenol combination pill for pain relief
There is only a headline; the United States Food and Drug Administration (FDA) has authorized a new version of Tylenol that combines ingredients for pain treatment without the need for a medical prescription. Due to the absence of additional information in the source, there are no details available regarding the specific components of the formula, the clinical studies conducted, or the exact impact this drug will have for patients.
French migraine treatment: a breakthrough for 11 million patients
There is only a headline; the news announces a new breakthrough in a treatment of French origin intended to benefit 11 million people suffering from migraine. As the full text of the source is not available, it is not possible to detail the drug's mechanism, the type of clinical study conducted, or the specific results achieved, with current information being limited solely to the magnitude of the population potentially impacted by this therapeutic innovation in the French country.
Atogepant reduces migraine days by half in three out of ten refractory patients
This Spanish multicenter study, led by the Hospital de Bellvitge with 252 refractory patients, analyzed the effectiveness of the preventive drug atogepant in highly complex cases. The results show that 30% of patients who had not responded to previous treatments, including monoclonal antibodies, reduced their migraine days by half after three months. For the patient, this represents new therapeutic hope in difficult cases, achieving significant improvements in pain intensity and a lower need for rescue medication.
New non-opioid analgesic, suzetrigine, reduces headache in single-center cohort
There is only a headline; it is announced that suzetrigine, a new non-opioid analgesic, has shown efficacy in reducing headache in a study conducted at a single research center. Since the full text is not available, details regarding the methodology, number of participants, or the exact magnitude of improvement are unknown. For the patient, this represents a possible future therapeutic alternative without the risks of opioids, although more data are required to confirm its actual clinical utility.
NICE approves atogepant for the acute treatment of migraine in the NHS of England
The British body NICE has approved the use of atogepant (Aquipta) as an acute treatment for adults with migraine in England. This gepant-type drug, which blocks CGRP, was already used as a preventive and can now be used during attacks. It is indicated for patients who have not responded to 2 triptans, paracetamol, or NSAIDs. For the patient, this represents a specific alternative for pain that reduces the risk of medication overuse headache and expands the available therapeutic options.
AEMPS starts the IPT for six drugs endorsed by the EMA in April
The Spanish Agency of Medicines (AEMPS) has started in Spain the preparation of the Therapeutic Positioning Report (IPT) for Aquipta (atogepant). After receiving European endorsement in April 2026, this drug seeks to expand its indication to include the acute treatment of migraine with or without aura in adults. For the patient, this represents a key administrative step toward the availability of a new therapeutic option to stop migraine attacks, pending its final price and reimbursement.
Anvisa approves migraine medication that dissolves in the mouth
There is only a headline; the National Health Surveillance Agency of Brazil has approved a new drug to treat migraine that is characterized by being a formulation that dissolves in the mouth. Due to the absence of additional information in the source, specific details about the commercial name of the product, its clinical efficacy, or when it will be available for patients in that country are not known.
Rimegepant for the acute treatment of migraine: a systematic review and meta-analysis
This meta-analysis of seven clinical trials evaluated the efficacy of 75 mg of rimegepant in 6,734 adults with migraine. The results show that 19.8% of patients achieved pain freedom at two hours, compared to 10.7% with placebo, and 14.2% maintained that relief for 24 hours. The drug proved to be safe and well-tolerated. For the patient, this confirms that rimegepant is an effective and safe option, especially useful if conventional treatments do not work or are contraindicated.
Systematic review and meta-analysis on the efficacy and safety of rimegepant for migraine
This meta-analysis of 5 studies with 5,565 participants evaluated the use of rimegepant for migraine. The results show that the drug is effective in achieving pain relief and eliminating the most bothersome symptom at 2 hours after treatment (RR=1.34 and 1.38 respectively). For the patient, rimegepant offers a safe and well-tolerated option without significant adverse effects compared to placebo, although the study warns that it failed to demonstrate statistical efficacy in preventing pain recurrence between 2 and 48 hours later.
This analysis of the ADVANCE and ELEVATE clinical studies evaluates the drug atogepant (Aquipta®), an oral CGRP receptor antagonist for patients with episodic migraine in Germany. The results show a significant reduction of 4.1 migraine days per month compared to 2.5 with placebo, with a 50% response rate in 60% of users. For the patient, this represents an effective preventive option that acts within a few days, even when other conventional treatments have previously failed.
Long-term safety and efficacy of rimegepant for the preventive treatment of migraine in Japan: an open-label extension of a phase 3 study
This phase 3 study in Japan evaluated the safety and efficacy of rimegepant 75 mg over 52 weeks in 458 adults with migraine. The results showed an average reduction of 4.5 migraine days per month, and 55.4% of participants managed to reduce their attacks by half. The drug was well tolerated, with only 1.3% discontinuing due to adverse effects. For the patient, this confirms that rimegepant is a safe and effective long-term option to prevent attacks and improve quality of life.
FDA: EFFICACY supplement for RIZAFILM (RIZATRIPTAN benzoate)
There is only a headline; the FDA has registered an efficacy supplement for Rizafilm (rizatriptan benzoate) under code NDA205394. The source text does not provide additional details regarding the type of study conducted, the numerical results obtained, or the specific changes this implies for patient treatment. This is a technical update concerning the efficacy information for this drug commonly used to treat migraine attacks.
This press article summarizes the pharmaceutical innovations recently approved in the EU. Among the 38 new active ingredients, the oral CGRP receptor antagonists stand out for migraine patients: rimegepant (Vydura) and atogepant (Aquipta). While atogepant is used exclusively for the prophylaxis of episodic migraine, rimegepant offers the versatility of serving for both preventive treatment and acute attacks. This expands oral therapeutic options, allowing for more personalized and specific management of the disease.
Gepants, ditans and monoclonal antibodies: the roadmap for Spanish Neurology to integrate the new therapeutic era in headaches
The Spanish Society of Neurology has published its fifth clinical guideline on headaches, which updates the treatment for more than five million patients in Spain. The document highlights the efficacy of monoclonal antibodies and the new gepants and ditans, which improve functional capacity and offset economic costs within three months. Despite the advances, the guide denounces access barriers in the public system. The patient will benefit from care that now integrates surgery, digital health, and exercise recommendations for the first time.
Fremanezumab in children and adolescents with episodic migraine
This randomized clinical trial evaluated the efficacy of fremanezumab in 234 participants aged 6 to 17 with episodic migraine. The results showed that the drug reduced the monthly average of migraine days by 2.5 compared to 1.4 in the placebo group, with 47.2% of patients reducing their attacks by half. For a young patient, this represents a new effective and safe preventive option, with injection site erythema being the most common adverse effect.
Neurology News Network: Notable FDA Approvals in 2025
The FDA expanded the indication of fremanezumab (Ajovy) to include the prevention of episodic migraine in pediatric patients aged 6 to 17 years with a minimum weight of 45 kg. Based on the phase 3 SPACE study with 237 children, the drug demonstrated superior efficacy to placebo over 12 weeks with a consistent safety profile. This milestone is fundamental for pediatric patients, as fremanezumab becomes the first anti-CGRP treatment approved for both adults and migraine prevention in children.
AbbVie to present Phase 3 ECLIPSE data demonstrating the superiority of atogepant (AQUIPTA®) over placebo in achieving pain freedom for the acute treatment of migraine at the 19th European Headache Congress
This Phase 3 clinical study (ECLIPSE) conducted with 1,223 adults in Europe, Asia, and the United Kingdom analyzed the drug atogepant for treating acute migraine attacks. The results show that 24.3% of patients achieved pain freedom two hours after treatment, compared to 13.1% in the placebo group, also meeting the goal of eliminating the most bothersome symptom. For the patient, this means that atogepant, already used as a preventive, could become a new effective option to stop migraine attacks at the moment they occur.
Addressing unmet needs in migraine: effectiveness of fremanezumab in real-world conditions in PEARL study participants with at least three previous preventive treatment failures
This post-hoc analysis of the European PEARL study evaluated the effectiveness of fremanezumab in 398 patients with episodic and chronic migraine who had previously failed three or more preventive treatments. The results showed that 53.8% of participants achieved a reduction in their monthly migraine days of at least 50% during the first six months. For the patient, this confirms that the drug is a safe and effective option in real clinical practice, even when other traditional preventive treatments have not worked correctly.
Marketing of Reyvow for migraine treatment suspended, according to the FDA
The pharmaceutical company Eli Lilly has decided to suspend the manufacturing of Reyvow (lasmiditan), a drug for the acute treatment of migraine with or without aura in adults approved in 2019. According to the FDA, this decision is due to commercial and competitive reasons, ruling out safety or efficacy issues. For the patient, this means that this 5-HT 1F receptor agonist will stop being available soon. Due to its sedative side effects and the restriction of not driving for eight hours after taking it, it is recommended to seek therapeutic alternatives with your specialist.
Enough of migraine, here are the new oral drugs that eliminate attacks in 7 out of 10 patients
This article details the impact of gepants (atogepant and rimegepant) in Italy, oral drugs that block the CGRP peptide. Studies published in Lancet show that 7 out of 10 patients control their attacks, achieving relief within two hours and efficacy for up to 48 hours. They are indicated for adults with episodic or chronic migraine (minimum 8 days per month) who did not respond to previous therapies. For the patient, this represents a prevention and acute treatment option funded by the public system that restores daily normality.
Migraine: a new innovative treatment with highly controlled access
There is only a headline; the news published by the outlet Le Soir reports on the existence of a new innovative treatment for migraine that stands out for having very restricted or controlled access for patients. Due to the absence of text in the source, it is not possible to detail the type of drug, the mechanism of action, the country of application, or the specific criteria required to receive this new therapeutic option.
Rimegepant for the acute treatment of migraine in adults not suitable for triptans: A phase 4 randomized, double-blind, placebo-controlled trial
This phase 4 clinical trial analyzed the efficacy of a 75 mg dose of rimegepant in 585 adults who cannot use triptans due to lack of efficacy, intolerance, or contraindications. The results showed that 55.9% of patients achieved pain relief at 2 hours, compared to 32.7% in the placebo group, in addition to improving functionality and reducing the need for rescue medication. For the patient, this confirms that gepants are a safe and effective alternative when conventional treatments fail or are contraindicated.
Phase 4, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and tolerability of rimegepant for the prevention of episodic migraine in adults with a history of inadequate response to traditional oral preventive medications
This multinational phase 4 trial evaluated rimegepant (75 mg) in 652 adults with episodic migraine who previously did not respond to 2 to 4 traditional preventive drugs. The results showed that rimegepant reduced monthly migraine days significantly more than placebo (-2.1 vs. -0.5 days) and increased the probability of reducing severe attacks by half by 20%. For the patient, this represents an effective and safe option to prevent attacks when common oral treatments have failed.
FDA approves botulinum toxin A for severe chronic migraine
There is only a headline; the U.S. Food and Drug Administration (FDA) has announced the approval of botulinum toxin type A specifically for the treatment of severe chronic migraine. Due to the absence of text in the source, data on clinical trials, attack reduction figures, or the specific population studied are not available. For the patient, this represents the confirmation of a regulated therapeutic option for severe cases of this condition.
New migraine drugs approved in the EU: "they are very well tolerated"
The EU has approved 'gepants' (atogepant and rimegepant), a new class of oral drugs for adults that block the CGRP receptor. Rimegepant stands out for being the first authorized for both prevention and acute treatment. Unlike triptans, they do not constrict blood vessels, being safe for patients with cardiovascular risk. Although a meta-analysis suggests an acute efficacy somewhat lower than triptans, their pill format and short duration offer a versatile and well-tolerated alternative to injectable antibodies.
FDA: efficacy supplement for Vyepti (eptinezumab-jjmr)
There is only a headline; the FDA has registered an efficacy supplement related to the drug Vyepti (eptinezumab-jjmr) under identifier BLA761119. Due to the brevity of the report, details regarding the type of study, the population analyzed, or specific result figures are not available. For the patient, this represents an administrative update in progress that does not yet allow for the determination of specific changes or additional benefits in their current migraine treatment.
Efficacy and safety of eptinezumab in a predominantly Asian population with chronic migraine: Results from the SUNRISE randomized, double-blind, placebo-controlled trial
This phase 3 clinical trial analyzed the efficacy of eptinezumab in 978 adults with chronic migraine, primarily from Asia. The study demonstrated that the 100 mg and 300 mg doses reduced monthly migraine days by 7.2 and 7.5 respectively, compared to 4.8 days in the placebo group. For the patient, this represents an effective preventive option that offers relief from the first day of treatment and a significant reduction in attacks with a well-tolerated safety profile.