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Amneal Resubmits FDA Application for Dihydroergotamine Autoinjector to Treat Migraines and Cluster Headaches

• Amneal Pharmaceuticals has resubmitted its New Drug Application (NDA) to the FDA for a dihydroergotamine (DHE) prefilled autoinjector, aimed at treating migraines and cluster headaches. • The resubmission addresses manufacturing concerns previously raised by the FDA, which led to a rejection of the initial application. • If approved, Amneal's product would be the first DHE autoinjector on the market, offering a convenient, ready-to-use solution for patients. • The FDA is expected to complete its review of the NDA in Q2 2025, potentially providing a new treatment option for severe headache sufferers.

Amneal Pharmaceuticals is making another attempt to secure FDA approval for its dihydroergotamine (DHE) prefilled syringe autoinjector, a treatment designed for acute migraine with or without aura and cluster headache in adults. The company recently resubmitted its New Drug Application (NDA) to the FDA, addressing manufacturing issues that previously led to a rejection.
The FDA's initial rejection came in the form of a complete response letter (CRL) citing facility inspection issues at a third-party manufacturing site. Amneal has since moved the production of the DHE autoinjector in-house to resolve these concerns. The agency is expected to complete its review of the resubmitted NDA in the second quarter of 2025.

Addressing a Critical Need in Headache Treatment

DHE is a well-established medication for migraines and cluster headaches, currently available as nasal sprays (Migranal, Trudhesa) and injections (D.H.E. 45). Amneal's autoinjector aims to provide a more convenient and user-friendly option. According to Amneal, the single-dose, ready-to-use pen requires no refrigeration, assembly, or priming, potentially improving ease of use for patients during acute attacks.
Joe Renda, Amneal’s speciality chief commercial officer, emphasized the potential benefits for patients, stating the product aims to provide lasting relief for tough-to-treat headaches, in a single-dose autoinjector without the need for assembly or travelling to the emergency room during these painful episodes.

Market Opportunity and Competition

While the exact market size for a DHE autoinjector is difficult to pinpoint due to the existing variety of DHE products, Amneal estimates a $50 million to $100 million US sales opportunity. The need is significant, with the American Migraine Foundation reporting that one in four US households has a member who suffers from migraine.
Amneal is not the only company to face challenges in gaining FDA approval for acute migraine treatments. Satsuma Pharmaceuticals received a CRL earlier this year for its DHE candidate STS101 due to chemistry, manufacturing, and control (CMC) issues.
In related news, Amneal also announced FDA approval for its generic version of exenatide, an injectable glucagon-like peptide-1 receptor agonist (GLP-1RA), referencing AstraZeneca’s Byetta.
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Reference News

[1]
Amneal files again for FDA approval of first dihydroergotamine autoinjector - Yahoo Finance
finance.yahoo.com · Nov 22, 2024

Amneal Pharmaceuticals resubmits NDA for DHE prefilled syringe autoinjector to FDA, addressing previous manufacturing co...

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