Impel (IMPL) Gets FDA Nod for Trudhesa in Migraine Treatment
The FDA approves Impel's (IMPL) Trudhesa nasal spray for the acute treatment of migraine with or without aura in adults.
Impel NeuroPharma, Inc. IMPL announced that the FDA has approved its lead product, Trudhesa nasal spray (0.725 mg per spray), for the acute treatment of migraine in adult patients with or without aura. The product is expected to be launched early next month.
The new drug application for Trudhesa was based on data from the phase III STOP 301 study. The primary goal of the study was to assess the safety and tolerability of Trudhesa. Data form the same showed that treatment with Trudhesa was generally well tolerated, and exploratory efficacy findings showed that it provided rapid, sustained and consistent symptom relief.
Data from the study showed that treatment with Trudhesa led to consistent efficacy even when taken late into a migraine attack, unlike other oral acute treatments that need to be taken within one hour of the attack to be most effective. There was no serious treatment-emergent adverse event reported in the STOP 301 study.
Per the company, following the FDA nod, Trudhesa became the first and only therapeutic to use precision olfactory delivery technology to deliver dihydroergotamine mesylate to the vascular-rich upper nasal space.
Shares of Impel have rallied 76.3% in the past three months compared with the industry’s rise of 2.1%.
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We remind investors that Impel started trading on the NASDAQ stock exchange following its initial public offering on Apr 23, 2021.
Aprat from Trudhesa (previously known as INP104), Impel has other pipeline candidates that are also making good progress. The company is developing INP105 for the acute treatment of agitation in patients with autism and INP107 for treating OFF episodes in Parkinson’s disease.
We note that the migraine market is heavily crowded with several anti-CGRP drugs like Amgen’s AMGN Aimovig, Lilly’s LLY Emgality, Teva’s Ajovy and AbbVie’s ABBV oral drug, Ubrelvy, already approved by the FDA for the given indication.
Impel currently has a Zacks Rank #4 (Sell). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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