BRIEF—Impel submits migraine NDA

Privately-held CNS specialist Impel NeuroPharma has submitted a New Drug Application (NDA) for INP104 (dihydroergotamine mesylate) to the US Food and Drug Administration (FDA) for the acute treatment of migraine headaches with or without aura in adult patients.

INP104 uses the Seattle-based company’s proprietary Precision Olfactory Delivery (POD) technology, a delivery system that uniquely targets the vascular-rich upper nasal space. It is Impel’s first therapeutic candidate to be submitted for US regulatory review.

Adrian Adams, chairman and chief executive officer of Impel, said: “The submission of INP104 represents our first NDA and marks a major milestone for Impel as we rapidly advance our pipeline of differentiated, potentially transformative therapies for people living with CNS disorders.

“Based upon the previously reported positive results of the STOP 301 study, we believe that INP104 has the potential to provide an important new option for people who need a fast, effective, and consistently reliable acute treatment of migraine headaches.”