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.
Approximate number of people who suffer from Cluster Headaches in the U.S.
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.
Source: Headache
Source: Journal of Headache and pain
Source: Headache
Source: Neurology and Therapy
Source: Future Market Insights
Source: International Headache Society
Source: Headache
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.
“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
Source: National Headache Foundation
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