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Impel NeuroPharma wins FDA approval for migraine nasal spray

The nasal spray uses proprietary delivery technology.

By Brian Buntz | September 3, 2021

Impel Neuropharma

(PRNewsfoto/Impel NeuroPharma)

Impel NeuroPharma (NSDQ:IMPL), a biopharma founded in 2008, has won FDA approval for Trudhesa (dihydroergotamine mesylate) nasal spray as an acute migraine therapy.

The Seattle-based company intends to launch the drug, formerly known as INP104, in early October 2021.

Impel plans to price the drug between $600 and $850 for a package with four doses.

The company will make the drug available via a pharmacy partnership and copay program.

Impel NeuroPharma is using proprietary technology that it has dubbed Precision Olfactory Delivery (POD). The delivery method supports the delivery of dihydroergotamine (DHE) mesylate to the upper nasal cavity, according to the press release.

“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,” said Adrian Adams, Impel NeuroPharma CEO, in a statement.

The indication covers migraines with and without aura.

The FDA approval was based on data from the Phase 3, open-label STOP 301 clinical trial, which Impel NeuroPharma bills as “the largest longitudinal study ever conducted with DHE using nasal spray delivery.”

Bausch Health currently has a nasal formulation of dihydroergotamine mesylate on the market known as Migranal but offers a less effective delivery method than Trudhesa, according to Reuters.

Impel NeuroPharma went public via an IPO in April.


Filed Under: clinical trials, Drug Discovery, Neurological Disease
Tagged With: DHE, dihydroergotamine mesylate, Impel NeuroPharma, migraine, Precision Olfactory Delivery, Trudhesa
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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