Migraine Market Enters New Era Following Satsuma Pharmaceuticals' ATZUMI and Amneal Pharmaceuticals' BREKIYA Regulatory Approval
The approval of ATZUMI and BREKIYA is expected to significantly reshape the migraine market by introducing new, innovative treatment options. These therapies promise improved efficacy and convenience, potentially capturing a substantial share from existing CGRP inhibitors. Their entry may intensify competition, drive pricing adjustments, and stimulate further innovation.
LAS VEGAS, May 21, 2025 /PRNewswire/ — Migraine is recognized globally as the seventh most disabling condition across all diseases, accounting for approximately 2.9% of all years lived with disability (YLDs). It is also the top cause of disability among neurological disorders. Despite its prevalence, migraine is often underdiagnosed and undertreated. Around 50% of sufferers go undiagnosed, and fewer than half seek medical consultation. In 2024, the estimated number of individuals living with migraine in the 7MM reached roughly 119 million.
Current migraine management involves a dual approach—acute treatment to relieve symptoms during an attack, and preventive strategies to reduce the frequency and intensity of future episodes. Acute therapies generally include triptans, nonsteroidal anti-inflammatory drugs (NSAIDs), and anti-nausea medications, which target symptoms like pain and nausea. Recently, more focus has been placed on preventive care for patients with frequent or debilitating migraines. This includes the use of medications such as beta-blockers, antiepileptic drugs, and CGRP (calcitonin gene-related peptide) inhibitors, along with lifestyle changes to identify and avoid migraine triggers.
Preventive or prophylactic treatments aim to decrease the frequency, severity, and duration of migraine attacks, as previously discussed. FDA-approved preventive agents include propranolol, timolol, divalproex sodium, OnabotulinumtoxinA (Botox), and topiramate. While other migraine medications have demonstrated efficacy, they lack formal FDA approval for migraine prevention. For forecasting purposes, these therapies are grouped into classes such as antiepileptics, antihypertensives, and neurotoxins. Notably, Botox stands out as the only FDA-approved non-daily injectable option for chronic migraine, offering fewer side effects compared to daily oral medications.
Learn more about the migraine therapeutic market @ Migraine Treatment Market
Eptinezumab (ALD-403), marketed as VYEPTI, is approved for the preventive treatment of migraines in adults. Aimovig, developed by Amgen and Novartis, was the first FDA-approved migraine prevention therapy from a new drug class that blocks CGRP, a key molecule involved in migraine episodes.
FDA approved EMGALITY in September 2019 for preventing migraine in adults, but it's contraindicated for those hypersensitive to galcanezumab-gnlm or its components. In November 2019, the EU approved galcanezumab for adults with ≥4 migraine days/month.
In September 2019, the FDA sanctioned AJOVY for adult migraine prevention. By January 2020, an autoinjector for Fremanezumab received FDA approval. In March 2019, AJOVY earned European Commission approval for adult migraine prophylaxis. Teva's AJOVY gained approval in Japan in June 2021.
In September 2021, Impel Pharmaceuticals gained FDA approval for TRUDHESA, a nasal spray formulation of dihydroergotamine mesylate (0.725 mg per spray), intended for the acute treatment of migraines with or without aura in adults.
In March 2023, Pfizer's ZAVZPRET (zavegepant) received FDA approval. It is the first CGRP receptor antagonist nasal spray approved for acute migraine treatment in adults, with or without aura, and uniquely utilizes Precision Olfactory Delivery (POD) technology, targeting the upper nasal cavity for drug delivery.
The FDA also approved QULIPTA (atogepant) in April 2023 for chronic migraine prevention in adults. It stands out as the first oral CGRP receptor antagonist approved for both episodic and chronic migraine prevention. In the same month, IntelGenx Corp announced FDA approval of RIZAFILM, designed for the acute treatment of migraines.
Additionally, in January 2025, the FDA approved AXS-07, an oral multi-mechanistic treatment for acute migraine attacks, developed by Axsome Therapeutics. Branded as SYMBRAVO, it is expected to launch in the U.S. approximately four months after FDA acceptance of the company's NDA resubmission in September 2024.
Dive deep into the United States migraine drugs market @ Migraine Headache Drugs Market
On April 30, 2025, the FDA approved ATZUMI, a nasal powder formulation of dihydroergotamine (DHE), developed by Satsuma Pharmaceuticals, for the acute treatment of migraines in adults. Satsuma is a subsidiary of Shin Nippon Biomedical Laboratories.
ATZUMI is a drug-device combination that uses Satsuma's proprietary Simple MucoAdhesive Release Technology (SMART) platform. The medication is administered through a squeezable device inserted into the nostril, delivering DHE in powder form.
The FDA had previously rejected ATZUMI's marketing application last year, citing concerns related to chemistry, manufacturing, and controls. However, no issues were raised about the clinical data, nor were additional trials requested.
The recent approval was supported by results from a Phase I pharmacokinetics study and the Phase III ASCEND trial. These trials showed that ATZUMI is rapidly absorbed, maintains high and sustained DHE plasma levels, and is safe for individuals with migraines. Over one-third of patients experienced pain relief within two hours of use.
Recently, in May 2025, Amneal Pharmaceuticals, Inc. announced that the FDA had approved BREKIYA (dihydroergotamine mesylate) injection, the first and only autoinjector form of dihydroergotamine (DHE) for the acute treatment of migraine with or without aura, as well as cluster headaches in adults. The product is expected to become available to eligible patients in the second half of 2025.
The BREKIYA autoinjector offers the possibility of sustained pain relief† in a convenient, self-administered format. It delivers the same DHE medication traditionally used in hospital settings but in a prefilled, ready-to-use device. The autoinjector does not require refrigeration, assembly, or priming, and is designed for subcutaneous injection into the middle of the thigh. This delivery method may be especially useful for patients who have a poor response to oral medications, experience nausea or vomiting during migraine attacks, have delayed gastric emptying, or tend to postpone treatment until symptoms have worsened.
To know more about the migraine treatment devices, visit @ Migraine Treatment Devices Market
Although standardized treatment guidelines are widely available and a range of mostly affordable options for both acute and preventive migraine therapies exist, there remains a significant unmet need, contrary to common belief. Many of the currently used treatments are not universally effective, may pose cardiovascular risks for some patients, and are either too general or poorly tolerated. Response rates remain suboptimal, breakthrough migraines are frequent, and patients often rely on multiple medications to manage symptoms. Additionally, side effects contribute to poor compliance and adherence. Studies indicate that about half of patients are dissatisfied with the ability of their current therapy to prevent recurring pain, and nearly 80% are open to trying new acute or preventive options.
Looking ahead, the migraine treatment landscape is poised for major transformation, driven by shifts in market dynamics that began around 2020. Advances in novel drug development and biomarker-based targeting are expected to significantly enhance revenue potential across the 7MM during the forecast period of 2025 to 2034. Some of the migraine drugs in the pipeline include ABP-450 (Axsome Therapeutics), Aimovig (AEON Biopharma, Inc.), Lu AG09222 (Lundbeck), and others.
Discover which therapies are expected to grab major migraine therapeutics market share @ Migraine Drugs Market
ABP-450, developed by AEON Biopharma, Inc., is an injectable formulation containing a 900 kDa botulinum toxin type-A complex derived from Clostridium botulinum. At therapeutic doses, it induces chemical denervation of muscles, leading to a localized decrease in muscle activity. The drug is currently undergoing Phase II clinical trials for the treatment of episodic and chronic migraine.
Aimovig, produced by Amgen, is a monoclonal antibody that targets and blocks the calcitonin gene-related peptide receptor (CGRP-R). Already approved for preventive migraine treatment, it is now being evaluated for migraine prevention in pediatric patients, covering both episodic and chronic forms.
Lu AG09222, an investigational monoclonal antibody from Lundbeck, is designed to bind to and inhibit pituitary adenylate cyclase-activating polypeptide (PACAP). PACAP is a neuropeptide involved in migraine pathophysiology, making it a promising novel target. Lu AG09222 is being explored as a preventive therapy for individuals suffering from migraine.
Discover more about migraine drugs in development @ Migraine Clinical Trials
The anticipated launch of these emerging migraine treatments are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the migraine market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
DelveInsight estimates that the migraine market size in the 7MM is expected to grow from USD 10.8 billion in 2023 at a significant CAGR by 2034. This expansion across the 7MM will be due to the rising awareness of the disease and incremental healthcare spending across the world, which would expand the migraine market size to enable the drug manufacturers to penetrate more into the migraine market.
DelveInsight's latest published market report titled Migraine Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the migraine country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The migraine market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into:
Total Prevalent Cases of Migraine
Gender-specific Prevalent Cases of Migraine
Severity-specific Prevalent Cases of Migraine
Diagnosed Cases of Episodic and Chronic Migraine
The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM migraine market. Highlights include:
10-year Forecast
7MM Analysis
Epidemiology-based Market Forecasting
Historical and Forecasted Market Analysis upto 2034
Emerging Drug Market Uptake
Peak Sales Analysis
Key Cross Competition Analysis
Industry Expert's Opinion
Access and Reimbursement
Download this migraine market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the migraine market. Also, stay abreast of the mitigating factors to improve your market position in the migraine therapeutic space.
Related Reports
Migraine Epidemiology Forecast
Migraine Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted migraine epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.
Migraine Pipeline
Migraine Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key migraine companies, including Satsuma Pharmaceuticals, Biohaven Pharmaceuticals, Allodynic Therapeutics, Vaxxinity, AbbVie, Pulmatrix, AEON Biopharma, Eli Lilly and Company, Trevena, Xoc Pharmaceuticals, Pharmaleads, Pear Therapeutics, among others.
Cluster Headache Market
Cluster Headache Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key cluster headache companies including Novartis AG, Zosano Pharma, Eli Lilly and Company, AstraZeneca Plc., Autonomic Technologies, Inc., ElectroCore Medical LLC., GlaxoSmithKline Plc, Winston Pharmaceuticals Inc., Lundback Seattle BioPharmaceutical, among others.
Cluster Headache Pipeline
Cluster Headache Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key cluster headache companies, including Lundbeck, Eli Lilly, AstraZeneca, GlaxoSmithKline, Zosano Pharma, GlaxoSmithKline, among others.
About DelveInsight
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve.
Contact Us
Shruti Thakurinfo@delveinsight.com +14699457679
Logo: https://mma.prnewswire.com/media/1082265/3528414/DelveInsight_Logo.jpg
View original content:https://www.prnewswire.co.uk/news-releases/migraine-market-enters-new-era-following-satsuma-pharmaceuticals-atzumi-and-amneal-pharmaceuticals-brekiya-regulatory-approval–delveinsight-302461477.html
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Malaysian Reserve
2 days ago
- Malaysian Reserve
NEDHSA to host JiggAerobics event
MONROE, La., June 6, 2025 /PRNewswire/ — Northeast Delta Human Services Authority (NEDHSA) is hosting its seventh JiggAerobics event beginning at 6 p.m. June 12 at Monroe Downtown River Market, 316 S. Grand St. NEDHSA Executive Director Dr. Monteic A. Sizer said the event provides a fun and upbeat activity for individuals of all ages and fitness levels. 'Fitness plays an important role in mental health and, when coupled with proper exercise, is a strong predictor of positive health outcomes,' Dr. Sizer said. 'By hosting events such as JiggAerobics, we are providing an opportunity for citizens of northeast Louisiana to engage in healthy activities and learn about the interconnectedness of their mental and physical health.' The event is part of NEDHSA's #getfitHSA initiative, which supports NEDHSA's integrated care model by increasing access to healthy activities and informing communities about the importance of staying fit and active. Data shows that heart disease, obesity and other physical illnesses are correlated with various forms of trauma, stress and mental illness, Dr. Sizer said. The event will be led by JiggAerobics founder LaDonte Lotts, also known as 'Mr. Get Right.' The dance-based fitness program fuses jigging — an energetic Louisiana dance style — with Lotts' dance moves and numerous plyometric exercises. NEDHSA consistently works to understand the unique health care needs of the citizens of Northeast Louisiana. 'Once we understand the needs and wishes of the people, we actively put programs and services in place to help meet people where they are,' Dr. Sizer said. Register for free tickets at
Malaysian Reserve
2 days ago
- Malaysian Reserve
Nuvia's Chief Clinical Officer, Dr. Preston Hansen, Featured as May Cover Story in CXO Magazine
SALT LAKE CITY, June 6, 2025 /PRNewswire/ — Nuvia Dental Implant Center's Chief Clinical Officer, Dr. Preston Hansen, has been featured as the May 2025 cover story of CXO Magazine—a global leadership magazine spotlighting industry changemakers. In the article titled 'Transforming Healthcare Through Life-Changing Patient Experiences,' Dr. Hansen shares his journey from a young dental student to now leading a monumental change in the dental implant industry with a new approach to full mouth restorations. The feature highlights just how groundbreaking Nuvia's process is. The ability to deliver permanent full-mouth dental implants just 24 hours after surgery is disrupting traditional care methods that have hardly been innovated for decades. With a new approach, Nuvia is restoring smiles, changing lives, and re-imagining the patient experience. In the Feature CXO covers Dr. Hansen's surgical background, his passion for patient care, and Nuvia's commitment to giving patients the smiles they've always wanted in a timeframe that not only promotes healing, but is extremely convenient for patients. Dr. Hansen shares about what treatment is like saying, 'We built everything around one promise: give people back their smiles and their lives in a way that's fast, safe, and predictable'. With a team of oral surgeons, restorative dentists, CRNAs, and in-house lab technicians, Nuvia has created a rare dental implant experience that prioritizes safety and comfort so patients never have to question if they're in good hands. The feature also distinguishes between the old and new method of approaching dental implants, emphasizing that Nuvia patients aren't given a temporary set of teeth after their dental implants are placed. The CXO feature also highlights Nuvia's recent national recognitions, including: 'Dental Restoration Company of the Year' — Awarded by Healthcare Business Review for both 2024 and 2025 99.13% implant success rate Thousands of lives transformed through a 24-hour permanent smile process 'Traditional treatment plans can take months or even years' Dr. Hansen says in the article. 'Our approach delivers a permanent solution in 24 hours—with fewer appointments, less downtime, and far more predictability.' To see first hand stories from Nuvia patients, check out Nuvia TV. About Nuvia Dental Implant Center Nuvia exclusively does full-mouth dental implants delivered with permanent teeth in just 24 hours—not temporary dentures. With a highly coordinated team approach, advanced imaging, and an in-house lab, Nuvia provides a safe, fast, and predictable alternative to traditional implant methods. With multiple U.S. locations and thousands of life-changing procedures completed each year, Nuvia is offering a proven, one and done treatment for those with missing or failing teeth. Media Contact: marketing@
Malaysian Reserve
2 days ago
- Malaysian Reserve
Wild About Sprouts® Celebrates World Food Safety Day with Breakthrough Cold-Grown® Technology That Redefines Safety and Nutrition
SCOTTSDALE, Ariz., June 6, 2025 /PRNewswire/ — In honor of World Food Safety Day June 7, Wild About Sprouts® is shining a spotlight on its revolutionary Cold-Grown® process—an all-natural, patented innovation that has redefined food safety standards in the sprouting industry. With over 25 million containers sold pathogen-free and never part of any recall over its 8+ years, Wild About Sprouts is the only national sprout brand in the U.S., now proudly available in over 7,000 grocery stores across the country. Sprouts are among the most powerful, studied, and nutrient-dense superfoods on the planet. Yet for decades, their potential has been limited by persistent food safety concerns. Wild About Sprouts has solved that problem. Its Cold-Grown® process eliminates the risk of dangerous pathogens without the use of pesticides, herbicides, or chemical intervention, and uses 95% less water than traditional growing systems—making it one of the most sustainable solutions in fresh food today. 'At Wild About Sprouts, food safety isn't a feature—it's the foundation,' said Barry Didato, CEO of Rä Foods, parent company of Wild About Sprouts. 'Our patented Cold-Grown® method is changing the way America eats—combining breakthrough safety with unmatched nutrition, delivering sprouts that contain up to 100 times more antioxidants, vitamins, and minerals than fully grown vegetables. Backed by over 2,000 studies, sprouts—especially broccoli sprouts—are rich in sulforaphane, a proven compound that supports the body's natural detox pathways, helps fight cancer, reduces inflammation, and shows promise in managing conditions like autism, diabetes, and neurodegenerative disease.' Observed every year on June 7, World Food Safety Day highlights the importance of safe, accessible food for all. Wild About Sprouts is proud to lead this charge—proving that innovation can make clean, nutrient-packed, fresh foods not just possible, but scalable. 'Wild About Sprouts has not only innovated with its Cold-Grown® technology—they've demonstrated an uncompromising commitment to public health,' said Dr. Darin Detwiler, Food Safety Advocate, Professor and Author of Food Safety: Past, Present, and Predictions. 'In an era when consumers demand both transparency and accountability, this company offers a clear model of how science and responsibility can align to create safer, more sustainable food systems. As we recognize World Food Safety Day, this kind of leadership is precisely what our food system needs to move from reaction to prevention.' Whether tossed in a salad, layered on a sandwich, or blended into smoothies, Wild About Sprouts products offer an easy and delicious way to boost everyday nutrition—safely. For more information, visit or follow us on Instagram at @wild_about_sprouts. Wild About Sprouts is available at major retailers including Kroger, Walmart, Whole Foods Market, Sprouts Farmers Market, Albertsons, and many more. About Wild About Sprouts®Founded in 2016 and based in Scottsdale, Arizona, Wild About Sprouts is transforming the sprout industry with its science-backed, Cold-Grown® technology. As part of Rä Foods, a family office dedicated to better-for-you innovations, Wild About Sprouts is on a mission to deliver safe, delicious, nutrient-dense foods that Make America Healthy Again—one sprout at a time.
