Posted by Michael Wonder on 21 Jan 2021
Impel NeuroPharma announces U.S. FDA acceptance of new drug application for INP104 for the acute treatment of migraine
20 January 2021 - FDA conditionally accepts trade name, Trudhesa, pending approval of the new drug application, and sets PDUFA goal date of 6 September 2021.
Impel NeuroPharma today announced that the U.S. FDA has accepted for review the company’s 5O5(b)(2) new drug application for INP104 for the acute treatment of migraine headaches with or without aura in adults.
INP104 is dihydroergotamine mesylate delivered directly into the vascular-rich upper nasal space using Impel’s proprietary Precision Olfactory Delivery (POD) technology.
If approved, INP104 will be marketed under the trade name, Trudhesa, in the U.S. and will become the first and only therapy to utilise the POD technology, a novel delivery system that specifically targets the vascular-rich upper nasal space.
