By Chris Wack

Impel NeuroPharma Inc. shares were up 20% to $27.69 after the company 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.

Volume for the stock was 4.1 million shares at 10:30 a.m. ET, compared with its 65-day average volume of 147,000 shares. The stock, which has a public float of 2.3 million shares, hit its 52-week high of $34.75 earlier in the session.

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.

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

(END) Dow Jones Newswires

09-03-21 1053ET