Impel NeuroPharma nasal spray to treat migraine gets USFDA okay
New Delhi: Impel NeuroPharma Inc's nasal spray to treat migraine got approval from the U.S. health regulator on Friday, marking the company's entry into a crowded market of medicines for a disease that affects about 39 million Americans.
The drug, Trudhesa, can be self-administered to the bloodstream by being sprayed in the upper part of the nasal canal and is formulated using dihydroergotamine (DHE), an agent that works on the serotonin receptors linked to migraine.
Impel will price the treatment between $600 and $850 for a pack containing four doses and is aiming for more than $500 million in peak sales, Chief Executive Officer Adrian Adams told Reuters.
The Seattle-based company, which went public in April, plans to commercially launch Trudhesa in early October. Its rivals include Biohaven Pharmaceutical's Nurtec ODT and AbbVie Inc's Ubrelvy, both of which are orally administered.
The market also has another intranasal DHE product, Migranal, whose commercial success has been held back by its less effective method of administration in the lower nasal cavity.
Cowen & Co analysts said the Trudhesa's differentiated nasal delivery method should help it find a solid role in the treatment paradigm.
Around 1 billion people worldwide suffer from migraines, according to the Migraine Research Foundation.
"We are taking this product to a population that wants DHE ... to be available in a consistent, predictable and trustworthy way," Impel's Adams said.
The approval comes with a strict Food and Drug Administration (FDA) warning that the treatment carries risks of potential impaired blood supply to the tissues when used together with certain enzyme inhibitors found in steroids.
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