Amneal Receives U.S. FDA Approval for Brekiya® (dihydroergotamine mesylate) injection for the Acute Treatment of Migraine and Cluster Headaches in Adults
Amneal Pharmaceuticals (NASDAQ: AMRX) has received FDA approval for Brekiya®, the first and only dihydroergotamine (DHE) autoinjector for acute treatment of migraine and cluster headaches in adults. The product will be available in H2 2025.
Brekiya represents a significant advancement as it allows patients to self-administer the same DHE medication used in hospitals through a convenient, ready-to-use autoinjector that requires no refrigeration, assembly, or priming. The device delivers one subcutaneous dose into the thigh and may provide sustained pain relief for up to 24-72 hours.
This innovation addresses a substantial market, with 39 million Americans suffering from migraines and up to 1 million affected by cluster headaches. Headaches represent the fourth most common reason for emergency department visits, accounting for 3% of all ER visits in the US.
Amneal Pharmaceuticals (NASDAQ: AMRX) ha ottenuto l'approvazione dalla FDA per Brekiya®, il primo e unico autoiniettore di diidroergotamina (DHE) per il trattamento acuto di emicrania e cefalee a grappolo negli adulti. Il prodotto sarà disponibile nella seconda metà del 2025.
Brekiya rappresenta un importante progresso, poiché permette ai pazienti di autogestire la stessa terapia a base di DHE utilizzata negli ospedali, grazie a un autoiniettore pronto all'uso, comodo, che non richiede refrigerazione, assemblaggio o preparazione. Il dispositivo somministra una dose sottocutanea nella coscia e può fornire un sollievo dal dolore prolungato fino a 24-72 ore.
Questa innovazione risponde a un mercato significativo, con 39 milioni di americani affetti da emicrania e fino a 1 milione colpiti da cefalee a grappolo. Le cefalee rappresentano la quarta causa più comune di accesso al pronto soccorso, costituendo il 3% di tutte le visite di emergenza negli Stati Uniti.
Amneal Pharmaceuticals (NASDAQ: AMRX) ha recibido la aprobación de la FDA para Brekiya®, el primer y único autoinyector de dihidroergotamina (DHE) para el tratamiento agudo de la migraña y las cefaleas en racimo en adultos. El producto estará disponible en la segunda mitad de 2025.
Brekiya representa un avance significativo, ya que permite a los pacientes autoadministrar el mismo medicamento DHE utilizado en hospitales mediante un autoinyector listo para usar, que no requiere refrigeración, montaje ni cebado. El dispositivo administra una dosis subcutánea en el muslo y puede proporcionar alivio sostenido del dolor durante 24 a 72 horas.
Esta innovación responde a un mercado considerable, con 39 millones de estadounidenses que sufren migrañas y hasta 1 millón afectados por cefaleas en racimo. Las cefaleas son la cuarta causa más común de visitas a urgencias, representando el 3% de todas las visitas a emergencias en EE.UU.
Amneal Pharmaceuticals (NASDAQ: AMRX)가 성인 급성 편두통 및 군발두통 치료를 위한 최초이자 유일한 디하이드로에르고타민(DHE) 자동주사기 Brekiya®에 대해 FDA 승인을 받았습니다. 이 제품은 2025년 하반기에 출시될 예정입니다.
Brekiya는 병원에서 사용하는 동일한 DHE 약물을 환자가 직접 편리하게 사용할 수 있는 준비된 자동주사기를 통해 제공하며, 냉장 보관, 조립 또는 예비 주사 과정이 필요 없는 점에서 큰 진전을 이뤘습니다. 이 장치는 허벅지에 피하 주사 한 회분을 투여하며 최대 24~72시간 동안 지속적인 통증 완화를 제공할 수 있습니다.
이 혁신은 3,900만 명의 미국인들이 편두통을 겪고, 최대 100만 명이 군발두통으로 고통받는 큰 시장을 대상으로 합니다. 두통은 미국 응급실 방문 사유 중 네 번째로 흔하며, 전체 응급실 방문의 3%를 차지합니다.
Amneal Pharmaceuticals (NASDAQ : AMRX) a obtenu l'approbation de la FDA pour Brekiya®, le premier et unique auto-injecteur de dihydroergotamine (DHE) destiné au traitement aigu de la migraine et des céphalées en grappe chez l'adulte. Le produit sera disponible au second semestre 2025.
Brekiya représente une avancée majeure en permettant aux patients d'auto-administrer le même médicament DHE utilisé à l'hôpital via un auto-injecteur prêt à l'emploi, pratique, ne nécessitant ni réfrigération, ni assemblage, ni amorçage. L'appareil délivre une dose sous-cutanée dans la cuisse et peut offrir un soulagement durable de la douleur pendant 24 à 72 heures.
Cette innovation répond à un marché important, avec 39 millions d'Américains souffrant de migraines et jusqu'à 1 million affectés par des céphalées en grappe. Les maux de tête constituent la quatrième cause la plus fréquente de visites aux urgences, représentant 3 % de toutes les consultations aux urgences aux États-Unis.
Amneal Pharmaceuticals (NASDAQ: AMRX) hat die FDA-Zulassung für Brekiya® erhalten, den ersten und einzigen Dihydroergotamin (DHE) Autoinjektor zur akuten Behandlung von Migräne und Clusterkopfschmerzen bei Erwachsenen. Das Produkt wird in der zweiten Hälfte des Jahres 2025 erhältlich sein.
Brekiya stellt einen bedeutenden Fortschritt dar, da es Patienten ermöglicht, das gleiche DHE-Medikament, das in Krankenhäusern verwendet wird, selbstständig über einen praktischen, gebrauchsfertigen Autoinjektor zu verabreichen, der keine Kühlung, Montage oder Vorbereitung benötigt. Das Gerät verabreicht eine subkutane Dosis in den Oberschenkel und kann eine anhaltende Schmerzlinderung von bis zu 24-72 Stunden bieten.
Diese Innovation richtet sich an einen bedeutenden Markt mit 39 Millionen Amerikanern, die an Migräne leiden, und bis zu 1 Million Betroffenen von Clusterkopfschmerzen. Kopfschmerzen sind der vierthäufigste Grund für Notaufnahmen und machen 3 % aller Notfallbesuche in den USA aus.
- First and only FDA-approved DHE autoinjector for self-administration of migraine and cluster headache treatment
- Addresses large market opportunity with 39 million migraine sufferers and 1 million cluster headache patients in the US
- Provides sustained pain relief lasting 24-72 hours
- No refrigeration, assembly, or priming required, improving convenience over existing options
- Can be used at any point during a migraine attack, potentially reducing emergency room visits
- Multiple contraindications and drug interactions that may limit patient eligibility
- Serious potential side effects including heart problems and stroke risks
- Limited to 3 doses in 24 hours and 6 doses in 7 days
- Some patients need to take their first dose in a healthcare provider's office
Insights
FDA approval of Brekiya gives Amneal a unique position in the large migraine market with potential for significant revenue impact.
The FDA approval of Brekiya represents a significant milestone for Amneal Pharmaceuticals and a potentially valuable addition to their specialty portfolio. This first-in-class DHE autoinjector addresses several unmet needs in the substantial migraine market affecting 39 million Americans and cluster headache market affecting up to 1 million Americans.
The product's unique positioning is its key advantage. As the first and only DHE autoinjector, Brekiya allows patients to self-administer the same medication used in hospitals without visiting emergency rooms. The market opportunity is substantial since headaches account for 3% of all ER visits in the US, representing the fourth most common reason for emergency department visits.
From a competitive standpoint, Brekiya offers several differentiating features: it doesn't require refrigeration, assembly, or priming, making it user-friendly. It's particularly valuable for patients who respond inadequately to oral therapies, experience nausea/vomiting during attacks, have gastroparesis, or delay dosing.
Importantly, this approval addresses the underserved cluster headache population where treatment options have been limited. The scheduled commercial availability in the second half of 2025 gives Amneal time to prepare their market launch strategy.
Amneal has historically focused on generics, so this specialty product represents continued execution of their strategy to expand into higher-margin branded products. This approval should help diversify their revenue streams while potentially improving their overall margin profile.
- Brekiya® becomes the first and only DHE autoinjector that allows patients to self-administer the same medication used in hospitals in a ready-to-use form
- Product will be available for appropriate patients in the second half of 2025
BRIDGEWATER, N.J., May 15, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved Brekiya® (dihydroergotamine mesylate) injection, the first and only dihydroergotamine (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 provides patients with the potential for sustained* pain relief† in a convenient, self-administered form.1,3,4 It contains the same medication (DHE) used in hospitals, now in a ready-to-use device.1,5 Brekiya autoinjector does not require refrigeration, assembly, or priming of the device.1 Patients can deliver one dose subcutaneously into the middle of the thigh.1 This may be beneficial for patients who respond inadequately to oral therapies due to lack of efficacy, experience nausea or vomiting during attacks, have gastroparesis, or delay dosing until too late into the attack.1,5,6
“We are thrilled to offer the first and only ready-to-use autoinjector for patients suffering from acute migraine and cluster headaches. Physicians are familiar with DHE, which is an effective and well-established therapy that provides sustained relief for headaches. Our single-dose autoinjector represents an innovative therapeutic option for patients that allows for quick self-administration of the medication during these painful attacks without visiting the emergency room,” said Joe Renda, Senior Vice President, Chief Commercial Officer – Specialty.
DHE is commonly administered in emergency rooms, urgent care facilities, and headache clinics intravenously. DHE can be used at any point during a migraine attack, and may protect patients from headache recurrence.1,3,4 Approximately 39 million Americans are living with migraine7, and up to one million with cluster headache.8 Also, headache is the fourth most common reason for emergency department visits, and accounts for
Do not take Brekiya autoinjector with strong CYP3A4 inhibitors including protease inhibitors and macrolide antibiotics. See additional Important Safety Information below.
Indication
Brekiya autoinjector is a prescription medicine used for the acute treatment of migraine with or without aura and acute 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.
IMPORTANT SAFETY INFORMATION
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.
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.
Please see full Prescribing Information, including Boxed Warning, Medication Guide, and Instructions for Use at Brekiya.com.
*Sustained represents a duration of approximately 24-72 hours2,3
†Cluster headache results reported using IV administration.4
References:
- Brekiya [package insert]. Bridgewater, NJ: Amneal Pharmaceuticals LLC; 2025.
- Data on File. Amneal Pharmaceuticals LLC.
- Winner P, Ricalde O, Le Force B, Saper J, Margul B. Arch Neurol. 1996;53(2):180-184.
- Mather PJ, Silberstein SD, Schulman EA, Hopkins MM. Headache. 1991;31(8):525-532.
- Silberstein SD, Shrewsbury SB, Hoekman J. Headache. 2020;60(1):40-57. doi:10.1111/head.13700
- Aurora SK, Papapetropoulos S, Kori SH, Kedar A, Abell TL. Cephalalgia. 2013;33(6):408-415.
- https://migraineresearchfoundation.org/about-migraine/migraine-facts/
- https://americanmigrainefoundation.org/resource-library/cluster-headache-2/
- Phelan, M, Thompson NR, Zubair A et al. Emergency department utilization among patients who receive outpatient specialty care for headache: A retrospective cohort study analysis. Headache. 2023;63:472–483.
Brekiya is a registered trademark of Amneal Pharmaceuticals LLC.
About Amneal
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceuticals, primarily within the United States. In its Affordable Medicines segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com and follow us on LinkedIn.
Cautionary Statement on Forward-Looking Statements
Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.
Investor Contact
Anthony DiMeo
VP, Investor Relations
anthony.dimeo@amneal.com
Media Contact
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Sr. Director, Corporate Communications
Brandon.skop@amneal.com
PP-PRS-DHE-US-0001 05/2025
FAQ
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