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