Acute Migraine Treatment INP104 Approved

Adrian Adams

The FDA has approved Impel NeuroPharma’s INP104 nasal spray for the acute treatment of migraine headaches with or without aura in adults. Marketed as Trudhesa, it is the first and only approved therapy that utilizes the Precision Olfactory Delivery (POD) technology, a novel delivery system that specifically targets the upper nasal space.1

INP104’s intranasal administration optimizes dihydroergotamine mesylate (DHE) for fast migraine relief regardless of when in the migraine attack it is administered. The drug delivery system is also designed to deliver a lower dose of DHE compared with other nasally administered, FDA-approved products, in turn reducing the adverse effects that are typically associated with delivery of DHE to the lower nasal space.

The FDA’s decision was based on data from the phase 3 STOP 301 study (NCT03557333), in which INP104 met the primary end point and demonstrated no new safety signals or concerning trends in nasal safety findings during the 52-week study period. The data were included in Impel’s new drug application (NDA), which was filed in November 2020 and accepted in January of this year.2

“We are delighted with the approval of Trudhesa and are proud to offer the millions of Americans with migraine a non-oral, acute treatment option that may provide rapid, sustained, and consistent relief, even when taken late into a migraine attack,” said Adrian Adams, chairman and chief executive officer, Impel NeuroPharma, in a statement.1 “The approval of Trudhesa marks the culmination of more than a decade of research and advanced engineering to pair the proven efficacy of DHE with our innovative POD technology.”