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 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 opportunit.