By Chris Wack

Impel NeuroPharma Inc. said the U.S. Food and Drug Administration approved Trudhesa dihydroergotamine mesylate nasal spray for the acute treatment of migraine with or without aura in adults.

The biopharmaceutical company said Trudhesa delivers dihydroergotamine mesylate quickly to the bloodstream through the vascular-rich upper nasal space, bypassing the gut and potential absorption issues.

The commercial launch of Trudhesa is planned for early October.

Impel said the New Drug Application for Trudhesa included the results of a Phase 3 safety study, where more than 5,650 migraine attacks were treated over 24 or 52 weeks during the study. The primary objective of the study was to assess the safety and tolerability of Trudhesa.

In the trial, Trudhesa was generally well tolerated and exploratory efficacy findings showed it provided rapid, sustained, and consistent symptom relief. There were no serious Trudhesa-related treatment-emergent adverse events observed in the study.

Impel shares were up 4%, to $23.94, in premarket trading before being halted.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

09-03-21 0922ET