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Migraine and Cluster Headaches

Migraine is the second-leading cause of disability globally.  In the U.S., 43 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. A migraine is more than just a headache; it’s a neurological disorder characterized by recurring episodes of moderate to severe head pain that can be deeply debilitating. Migraine is often described as throbbing or pulsating pain 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 three 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. Accurate diagnosis can be challenging, and many individuals are initially misdiagnosed, delaying appropriate treatment options. 

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.  

U.S. population 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

Accessibility trends

After decades of misunderstanding migraine and cluster headache, innovation is helping people access relief

Affordability

Stable
The affordability of treating headache disorders is nuanced and evolving. Meaningful therapeutic advances often come at a significant price premium relative to existing options, but are in some cases effective enough to significantly reduce hospitalizations, which are typically much more expensive. 
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.

Source: Journal of Managed Care & Specialty Pharmacy

Income class of those with the greatest prevalence of migraine
Socioeconomic data show that individuals living below the poverty threshold and under an annual income of $35,000 have the highest prevalence of migraine attacks

Source: Journal of Headache and pain

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 (~700 in U.S.), long wait times, and uneven geographic distribution, particularly for patients with chronic or refractory disease. Telemedicine has helped expand reach, but capacity constraints remain. 
Headache specialists in the U.S.
~700

Source: Headache

Average wait for a headache specialist appointment, in months
3.7

Source: Neurology and Therapy

Adherence rate with telemedicine and telemonitoring in migraine care
96.7%

Source: Computational and structural biotechnology journal

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

Source: Future Market Insights

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 care.
On average, it takes 5 years from symptom onset for an individual to receive an accurate diagnosis.

Source: National Library of Medicine

Proportion of patients for whom migraine is underdiagnosed or undertreated
50%

Source: International Headache Society

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 headache community

Amneal is committed to improving care for people living with migraine and cluster headache by expanding access to effective treatments

For people living with migraine and cluster headaches, the challenge extends beyond pain to include limited access to effective treatment options.

To help address this gap, Amneal introduced BREKIYA® (dihydroergotamine mesylate), the first and only DHE autoinjector for the acute treatment of migraine with or without aura and the acute treatment of cluster headaches in adults.(1,2) BREKIYA autoinjector is a ready-to-use, single-dose autoinjector that allows patients to self-inject directly into the thigh, enabling them to access treatment from the comfort of home. It can be effective at any point during an attack. With no refrigeration, assembly, or preparation required, it removes barriers to timely, effective treatment.

1. Brekiya [package insert]. Bridgewater, NJ: Amneal Pharmaceuticals LLC; 2025.
2. Data on file, Amneal Pharmaceuticals LLC.

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 may reduce 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
BREKIYA® (dihydroergotamine mesylate) injection
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

Cluster headache attacks are often misdiagnosed in emergency settings and may be mistaken for less severe conditions. Because they can last between 15 minutes to 3 hours, the attack may be over before a patient is seen.

Source: Medicina , Annals of Indian Academy of Neurology

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.

The views and opinions expressed in this index do not necessarily reflect those of Amneal, its affiliates, or its employees. Amneal disclaims any liability for any decisions made or actions taken based on the information contained herein.

This index is intended to support awareness and understanding of medicine accessibility and is not a substitute for professional consultation or regulatory guidance. Users are encouraged to verify information independently and consult appropriate experts before making decisions.

By using this site, you acknowledge and agree to these terms.

Serious or potentially life-threatening reductions in blood flow to the brain or extremities due to interactions between dihydroergotamine (the active ingredient in Brekiya autoinjector) with strong CYP3A4 inhibitors (such as protease inhibitors and macrolide antibiotics) have been reported rarely. As a result, these medications should not be taken together.

Do not use Brekiya autoinjector if you:
  • are taking medicines known as strong CYP3A4 inhibitors, such as: ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, ketoconazole, or itraconazole.
  • have heart problems or a history of heart problems, or uncontrolled high blood pressure.
  • have narrowing of blood vessels in your legs, arms, stomach, or kidneys (peripheral vascular disease).
  • have sepsis, had vascular surgery, severe liver or kidney problems.
  • are allergic to dihydroergotamine, ergot alkaloids, latex, or any of the ingredients in Brekiya autoinjector.
  • have taken any of the following medicines in the last 24 hours: sumatriptan, frovatriptan, ergotamine or ergotamine-type medicines, almotriptan, naratriptan, zolmitriptan, eletriptan, or rizatriptan
  • have taken any medicines that constrict your blood vessels or raise your blood pressure.
Before you take Brekiya autoinjector, tell your healthcare provider about all your medical conditions, including if you:
  • have high blood pressure, liver problems, or kidney problems.
  • have risk factors for heart disease, such as: high blood pressure, high cholesterol levels, smoke, are overweight, diabetes, family history of heart disease.
  • are pregnant or plan to become pregnant. Brekiya autoinjector may cause preterm labor. Brekiya autoinjector should be avoided during pregnancy. Talk to your healthcare provider right away if you are pregnant or want to become pregnant.
  • are breastfeeding or plan to breastfeed. Brekiya autoinjector may reduce breast milk supply and pass into your breast milk. Brekiya autoinjector may be harmful to your baby. Do not breastfeed your baby while taking Brekiya autoinjector and for 3 days after you use Brekiya autoinjector. Talk with your healthcare provider about the best way to feed your baby if you take Brekiya autoinjector.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take: sumatriptan, ergot-type medicine, saquinavir, nefazodone, fluconazole, grapefruit juice, zileuton, nicotine, propranolol or other medicines that can lower your heart rate, any medicines that can increase your blood pressure, selective serotonin reuptake inhibitors. These are not all of the medicines that could affect how Brekiya autoinjector works. Your healthcare provider can tell you if it is safe to take Brekiya autoinjector with other medicines.

How should I use Brekiya autoinjector?
  • Certain people should take their first dose of Brekiya autoinjector in their healthcare provider’s office or in another medical setting.
  • Brekiya autoinjector is for injection under the skin (subcutaneous) only.
  • Use Brekiya autoinjector exactly as your healthcare provider tells you to use it.
  • Each autoinjector contains one dose (1 mg).
  • If your headache comes back after the first complete dose, you may give yourself up to 2 more doses as needed. Wait at least one hour between doses.
  • Do not inject more than 3 doses (3 mg) of Brekiya autoinjector in a 24‑hour period or 6 doses (6 mg) in a 1‑week (7 day) period.
What are the possible side effects of Brekiya autoinjector?
Brekiya autoinjector can cause serious side effects, including:
  • Heart attack and other heart problems. Heart problems may lead to death. Stop taking Brekiya autoinjector and get emergency medical help right away if you have any symptoms of a heart attack, such as: numbness or tingling in your fingers and toes, muscle pain or cramps in your arms and legs, weakness in your legs, temporary speeding or slowing of your heart rate, or swelling or itching. Brekiya autoinjector is not for people with risk factors for heart disease unless a heart exam is done and shows no problem.
  • Stroke. Stop using Brekiya autoinjector and get emergency medical help right away if you have any of the symptoms of a stroke.
  • Changes in color or sensation in your fingers and toes (Raynaud’s syndrome).
  • Stomach and intestinal problems.
  • Increased blood pressure.
  • Medicine overuse headache. Some people who use too much Brekiya autoinjector may make their headaches worse. If your headaches get worse, your healthcare provider may decide to stop your treatment with Brekiya autoinjector.
  • Preterm labor.
  • Tissue changes (fibrotic complications). Inflammation and fiber-like tissue that is not normal (fibrosis) can occur around the lungs and stomach.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of Brekiya autoinjector. Call your healthcare provider for medical advice about side effects.

How should I store Brekiya autoinjector?
  • Store at room temperature between 68°F to 77°F (20°C to 25°C). Do not refrigerate or freeze.
  • Protect Brekiya autoinjector from light.
  • Keep Brekiya autoinjector in the original pack until ready to use.
Indication

Brekiya autoinjector is a prescription medicine used for the acute treatment of migraine with or without aura and the acute treatment of cluster headaches in adults.

Brekiya autoinjector is not used to prevent migraine or used to treat other types of headaches such as hemiplegic migraines (that make you unable to move on one side of your body) or basilar migraines (rare form of migraine with aura). It is not known if Brekiya autoinjector is safe and effective in children.

To report SUSPECTED ADVERSE REACTIONS, contact Amneal Specialty, a division of Amneal Pharmaceuticals LLC at 1‑877‑835‑5472, or FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch. (Opens in a new window)

Please see full Prescribing Information (Opens in a new window), including Boxed Warning, Medication Guide (Opens in a new window) (Opens in a new window), and Instructions for Use.

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