Amneal Pharmaceuticals has submitted another new drug application (NDA) for its dihydroergotamine (DHE) prefilled syringe autoinjector to treat tough-to-treat headaches, after being previously rejected.
The resubmitted filing to the US Food and Drug Administration (FDA) addresses manufacturing concerns raised by the agency when it issued Amneal a complete response letter (CRL). A review of the NDA, which is for the acute treatment of migraine with or without aura and cluster headache in adults, is expected to be completed in Q2 2025, as per a 21 November press release.
Amneal has not publicly disclosed when the CRL was issued and did not immediately reply to Pharmaceutical Technology when asked for confirmation of the date. The company has only stated that the rejection was due to “facility inspection issues at a third-party site”. The company has since moved production of the compound in-house to address this.
DHE is an established medication used to treat migraines and cluster headaches. It is sold under brand names such as Migranal, Trudhesa, and D.H.E 45, where administration is via nasal spray or injection. If approved, Amneal’s product would be the first and only DHE autoinjector on the market.
The drugmaker says the single-dose, ready-to-use pen would not require refrigeration, assembly, or priming, and allow more convenient dosing.
The market opportunity for an autoinjector is hard to quantify due to the number of DHE products currently on the market, but Amneal estimates a “$50m to $100m US sales opportunity”, based on a company presentation from June 2024. One in four households in America has a household member who suffers migraine, according to the American Migraine Foundation.
Amneal’s speciality chief commercial officer Joe Renda said: “We are excited to be one step closer to providing a new ready-to-use solution for patients suffering from severe migraines and cluster headaches. [The product] provides 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.”
Amneal hasn’t been the only one to fall short of FDA approval for acute migraine treatment, US-based Satsuma Pharmaceuticals received a CRL in January this year relating to chemistry, manufacturing, and control (CMC) issues with its DHE candidate STS101. In the same release announcing its NDA resubmission, Amneal also reported it has received FDA approval for exenatide – a generic injectable glucagon-like peptide-1 receptor agonist (GLP-1RA). The approval is for the 1.2ml and 2.4ml prefilled pen injections that reference AstraZeneca’s Byetta.
