Impel's NDA for migraine drug accepted by FDA

Privately-held Seattle, USA-based biopharma Impel NeuroPharma has announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for INP104 for the acute treatment of migraine headaches with or without aura in adults.

INP104 is dihydroergotamine mesylate (DHE) delivered directly into the vascular-rich upper nasal space using Impel’s Precision Olfactory Delivery (POD) technology.

"The FDA’s acceptance of our submission package for Trudhesa marks another important step in our journey to bring an important new treatment option to patients who, despite recent treatment advances, are still in need of a fast, effective, and consistently reliable relief from their migraine"If approved, INP104 will be marketed under the trade name Trudhesa in the USA. It will become the first and only therapy to use the POD technology.