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Migraine and Cluster Headaches

Migraine is the second-leading cause of disability globally.  In the U.S., 42 million Americans live with migraine,  disrupting daily life in profound ways 

Headache disorders are characterized by recurrent headaches and impact over 40% of the global population. One of the most prevalent headache disorders is migraine disorder. A migraine is more than just a light headache; it’s a neurological disorder characterized by recurring episodes of moderate to severe head pain that can be deeply debilitating. Migraine pain is often described as throbbing or pulsating and may last from several hours to as long as 72 hours if left untreated. For many people, migraine makes it difficult to work, maintain relationships, enjoy hobbies, or manage basic self-care. A migraine attack is frequently accompanied by additional symptoms, including: nausea, vomiting, sensitivity to light, sound, smell, or touch.

Although cluster headaches share some similarities with migraine, they are a distinct neurological disorder with unique characteristics. Cluster headaches occur in short but intensely painful attacks, typically lasting 15 minutes to two hours, and often appear in recurring cycles or “clusters” over weeks or months. The pain associated with cluster headaches is sudden, severe, and piercing, usually concentrated on one side of the head, often in or around the eye. It is frequently noted as one of the most painful conditions a person can experience, described as a “red hot needle.”  It can be accompanied by excessive tearing or redness of the eye, swelling around the eye, facial sweating or flushing, and nasal congestion or a runny nose on the affected side. Cluster headache affects approximately 1 in 1,000 people and is more common in men. Accurate diagnosis can be challenging, and many individuals are initially misdiagnosed, delaying appropriate treatment options. 

Americans affected by Migraine headaches

43,000,000

Source: Headache Journal

Proportion of U.S. men and women who suffer from Migraine

Source: Headache

Approximate number of people who suffer from Cluster Headaches in the U.S.

300,000

Source: Fischera M et al. Cephalalgia

Despite the severity and prevalence of migraine and cluster headache, treatment options have historically fallen short. Headache disorders are the fourth most common reason for emergency department visits in the United States. Yet, emergency care often exacerbates symptoms rather than relieves them—long wait times, bright lights, noisy environments, and rushed evaluations can intensify pain and distress for headaches.  

Accessibility trends

After decades of misunderstanding Migraine and Cluster headaches, innovation is helping people access relief

Affordability

Stable
Despite meaningful therapeutic advances, affordability remains a significant barrier for many patients with headache disorders. Newer treatments often carry high list prices and are subject to coverage restrictions, which can delay or prevent access. While generics help with cost, and older therapies are inexpensive, cost can remain a limiting factor for the newest treatment options and for patients with restrictive coverage or high co-pays. 
Average added cost for people with Migraine disorders compared to those without Migraine disorders
$6,575/yr.

Source: Headache

Estimated direct and indirect health care costs in the United States related to Migraine disorders
$30B/yr.
Income class of those with the greatest prevalence of Migraine
Below poverty

Availability

Stable
Most patients receive headache care in primary care settings, with limited access to specialists. There is a well-documented shortage of headache specialists, long wait times, and uneven geographic distribution, particularly for patients with chronic or refractory disease. Telemedicine has helped expand reach, but capacity constraints remain. 
Proportion of headache specialists vs. need for headache specialists
15%

Source: Headache

Average wait for a headache specialist appointment, in months
3.7
Adherence rate with telemedicine and telemonitoring in migraine care
96.7%

Innovation

Accelerating
After decades of limited progress, headache disorders are experiencing a surge in innovation. Digital resources, telehealth services, mobile applications, wearable devices, and AI applications are becoming fundamental elements to enhance patient care and lead to better health outcomes for those struggling with headache disorders.  
Amount the global migraine treatment market is expected to grow in the next ten years
2025
$3.46B
2035
$5.12B

Knowledge

Improving
Awareness of migraine and other headache disorders as serious, disabling neurological diseases is increasing among clinicians, patients, and the public. Improved diagnostic criteria, clinical guidelines, and patient advocacy efforts are helping reduce underdiagnosis and stigma, though many patients still go years without appropriate diagnosis or preventive care.
Proportion of patients for whom Migraine is underdiagnosed or undertreated
50%
Proportion of people with migraine disorder who reported a 50% or greater reduction in headache frequency by partaking in the Mercy Migraine Management Program (MMMP), an educational program for physicians and patients, showing the importance of adequate education
46%

Source: Headache

Amneal’s commitment to the Migraine and Cluster Headaches community

Amneal is committed to improving care for people living with Migraine and Cluster Headaches by expanding access to effective, targeted treatments

For people living with migraines and cluster headaches, the challenge extends beyond pain to include limited access to effective, targeted treatment options. As a result, approximately 40% of people living with migraine report dissatisfaction with their current therapy, and 74% say their treatment does not work well enough to manage symptoms—highlighting a significant unmet need.

To help address this gap, Amneal created BREKIYA® autoinjector (dihydroergotamine mesylate), the first and only prescription autoinjector containing dihydroergotamine (DHE) for the acute treatment of migraine with or without aura and cluster headache. BREKIYA autoinjector is a ready-to-use, single-dose autoinjector that allows patients to self-inject directly into the thigh, enabling them to begin treatment quickly from the comfort of home. It can be used at any point during an attack and is intended to help reduce headache recurrence. With no refrigeration, assembly, or preparation required, it removes barriers to timely, effective treatment.

In addition to BREKIYA autoinjector, Amneal offers ZOMIG® (zolmitriptan) Nasal Spray, providing another self-administered option for acute migraine treatment. Nasal delivery can be especially helpful for patients who experience migraine-related nausea, have difficulty taking oral medications, or do not have liquids available.

Patient
“We are excited to introduce Brekiya autoinjector, making this innovative therapy broadly available to healthcare providers and patients. As the first and only self-administered, ready-to-use DHE autoinjector, Brekiya autoinjector offers patients the ability to treat debilitating attacks in a convenient way and avoid visits to the emergency room. With our expanding neurology portfolio, Amneal is committed to supporting providers through comprehensive education and ensuring strong patient access as we bring Brekiya autoinjector to market.”
Joe Renda
Senior Vice President, Chief Commercial Officer – Specialty
ZOMIG® (zolmitriptan) Nasal Spray
Learn more
Headache disorders are the fourth most common reason for U.S. emergency department visits visits—Amneal is focused on self-administered treatments that help reduce unnecessary emergency care

Source: Headache: The Journal of Head and Face Pain

Percentage of people with migraine that are extremely dissatisfied with their current ability to control their disease — This is who we are working to help as we continue to innovate in this space
50%

Source: National Headache Foundation

BREKIYA® dihydroergotamine mesylate) autoinjector
Learn more

The information presented in this Accessibility Index is compiled from publicly available sources believed to be reliable at the time of publication. However, Amneal makes no representations or warranties, express or implied, regarding the accuracy, completeness, or timeliness of the data provided. The content is for informational purposes only and does not constitute professional advice or endorsement.

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