Amneal Launches Brekiya® – the First and Only DHE Autoinjector for Adults with Migraine With or Without Aura and Cluster Headaches

Rhea-AI Summary

Amneal (Nasdaq: AMRX) launched Brekiya® (dihydroergotamine mesylate) autoinjector on October 27, 2025, the first ready-to-use DHE autoinjector approved in the U.S. for acute treatment of migraine with or without aura and acute cluster headaches in adults.

Brekiya is available by prescription exclusively through Walgreens Specialty Pharmacy and Sterling Specialty Pharmacy. Eligible commercially insured patients may pay as little as $40 per carton (4 single-dose autoinjectors). Important boxed warning: do not coadminister with strong CYP3A4 inhibitors due to rare reports of peripheral ischemia.

Positive

• First-to-market: only ready-to-use DHE autoinjector
• Exclusive specialty distribution via Walgreens and Sterling
• Patient cost support: eligible insured may pay $40 per carton
• Field reimbursement specialists available to aid access

Negative

• Boxed warning: peripheral ischemia when used with strong CYP3A4 inhibitors
• Multiple contraindications including recent triptan or ergot use within 24 hours
• Dosing limits: max 3 mg/24 hours and 6 mg/week
• Not studied or indicated in children; pregnancy and breastfeeding warnings

Insights

Pharmaceutical Commercial Strategist

Amneal launched Brekiya, the first ready-to-use DHE autoinjector, now available through two specialty pharmacies.

Brekiya provides a self-administered, subcutaneous 1 mg DHE autoinjector for the acute treatment of migraine with or without aura and acute cluster headaches in adults, launched Oct. 27, 2025 and distributed exclusively via Walgreens Specialty Pharmacy and Sterling Specialty Pharmacy. The product positions Amneal to convert some emergency‑room or clinic infusions into at‑home treatments, and the announced $40 co-pay support per carton (4 autoinjectors) may lower initial access friction for commercially insured patients.

Key dependencies and risks include the boxed warning about serious peripheral ischemia with strong CYP3A4 inhibitors, multiple contraindications, and a complex dosing limit (maximum 3 doses/24 hours and 6 doses/week), which constrain use and require careful prescriber counseling. The exclusive specialty pharmacy pathway centralizes access but could limit reach to patients outside those networks or with different coverage. Monitor formulary placement, prior‑authorization frequency, specialty pharmacy fulfillment metrics, and early real‑world adverse event reports; expect meaningful signals on access and uptake within the first 90 days post-launch as reimbursement and patient assistance workflows stabilize.

• Brekiya^® autoinjector, a new specialty therapy from Amneal, is now available for prescription exclusively through Walgreens Specialty Pharmacy and Sterling Specialty Pharmacy
  

BRIDGEWATER, N.J., Oct. 27, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced the U.S. commercial launch of Brekiya^® (dihydroergotamine mesylate) injection, the first and only ready-to-use dihydroergotamine (DHE) autoinjector approved for the acute treatment of migraine with or without aura and the acute treatment of cluster headaches in adults.^1,2 The Brekiya autoinjector is now available by prescription exclusively through Walgreens Specialty Pharmacy and Sterling Specialty Pharmacy.

“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 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,” said Joe Renda, Senior Vice President, Chief Commercial Officer – Specialty.

Migraine affects approximately 43 million Americans³, and about 300,000 live with cluster headache.⁴ Headache disorders are also the fourth most common reason for U.S. emergency department visits, accounting nearly for 3% of cases.⁵ There are limited treatment options available for cluster headache, and Brekiya autoinjector represents a new treatment option for this underserved population.²

Information for Physicians and Patients:

• Brekiya is available only through prescription.
• Eligible commercially insured patients may pay as little as $40 per carton (4 single-dose autoinjectors per carton), applied automatically through the specialty pharmacy.
• To support healthcare providers, field reimbursement specialists will be available to assist with patient access, coverage and reimbursement questions.
  
  

Do not take Brekiya with strong CYP3A4 inhibitors including protease inhibitors and macrolide antibiotics. See additional Important Safety Information below.

Indication

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

Brekiya 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 is safe and effective in children.

IMPORTANT SAFETY INFORMATION
BOXED WARNING:
WARNING: PERIPHERAL ISCHEMIA FOLLOWING COADMINISTRATION WITH STRONG CYP3A4 INHIBITORS
Serious or potentially life-threatening reductions in blood flow to the brain or extremities due to interactions between dihydroergotamine (the active ingredient in Brekiya) 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 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.
• have taken any of the following medicines in the last 24 hours, before intended administration: 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, 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 may cause preterm labor. Brekiya 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 may reduce breast milk supply and pass into your breast milk. Brekiya may be harmful to your baby. Do not breastfeed your baby while taking Brekiya and for 3 days after you use Brekiya. Talk with your healthcare provider about the best way to feed your baby if you take Brekiya.
  
  

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 works. Your healthcare provider can tell you if it is safe to take Brekiya 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 is for injection under the skin (subcutaneous) only.
• Use Brekiya 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.
• Using BREKIYA for 10 or more days in 1 month may make your headache worse.
  
  

What are the possible side effects of Brekiya?
Brekiya can cause serious side effects, including:

• Heart attack and other heart problems. Heart problems may lead to death. Stop taking Brekiya 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 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, such as face drooping, slurred speech and unusual weakness.
• 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 may make their headaches worse. If your headaches get worse, your healthcare provider may decide to stop your treatment with Brekiya.
• Preterm labor.
• Tissue changes (fibrotic complications). Inflammation and fiber-like tissue that is not normal (fibrosis) can occur around the lungs and stomach.
• The most common but serious side effects of Brekiya are heart problems that happen but may lead to death. These heart problems include:
  • temporary squeezing of arteries that supply the heart (coronary artery vasospasm)
  • temporary decrease of blood flow to the heart (transient myocardial ischemia)
  • heart rhythm problems (ventricular tachycardia and ventricular fibrillation).
    
    

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. Call your healthcare provider for medical advice about side effects.

How should I store Brekiya?

• Store at room temperature between 68°F to 77°F (20°C to 25°C). Do not refrigerate or freeze.
• Protect Brekiya from light.
• Keep Brekiya 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.

References:

1. Brekiya package insert. Bridgewater, NJ: Amneal Pharmaceuticals LLC; 2025.
2. Data on File. Amneal Pharmaceuticals LLC.
3. Cohen F, et al. Headache. 2024;64(5):516-532.
4. Fischera M et al. Cephalalgia. 2008;28(6)614-618.
5. 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.
   
   

Note: 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 

FAQ

What is Brekiya (AMRX) approved to treat in adults?

Brekiya is approved for acute treatment of migraine with or without aura and acute cluster headaches in adults.

Where can patients fill a prescription for Brekiya (AMRX) in the U.S.?

Brekiya is available by prescription exclusively through Walgreens Specialty Pharmacy and Sterling Specialty Pharmacy.

How much does Brekiya (AMRX) cost for eligible commercially insured patients?

Eligible commercially insured patients may pay as little as $40 per carton (4 single-dose autoinjectors), applied automatically through the specialty pharmacy.

What major safety warning should prescribers of Brekiya (AMRX) note?

Boxed warning: do not coadminister Brekiya with strong CYP3A4 inhibitors due to rare but serious peripheral ischemia reports.

What are the dosing limits for Brekiya (AMRX) autoinjector?

Each autoinjector is 1 mg; up to 3 doses (3 mg) per 24 hours and up to 6 doses (6 mg) per 7-day period.

Are there patient-access resources for Brekiya (AMRX)?

Yes—Amneal provides field reimbursement specialists and specialty pharmacy support for coverage and access questions.