Impel NeuroPharma has announced the initiation of a Phase 1 trial of INP104 intranasal dihydroergotamine (DHE), which the company is developing for the treatment of acute migraine headache.
The bioavailability study, which is taking place in Australia, will compare INP104 to an approved intravenous DHE formulation and to Valeant’s Migranal DHE nasal spray, the company said.
Impel Founder and Chief Scientific Officer John Hoekman said, “This Phase 1 bioequivalence trial will provide initial safety and tolerability data for INP104, and if predetermined, comparative bioavailability is proven, these data will serve as the basis for enabling a pivotal safety study of INP104 in 2018, with the intent to file a new drug application (NDA) in 2019.”
Recently appointed Impel CEO Jon Congleton commented, “We believe the consistent, reliable, dose-to-dose delivery of product via Impel’s POD intranasal device holds the promise to improve systemic levels of DHE that were previously unachievable without injection. Migraine affects more than 36 million people in the United States, and over a third of these have breakthrough acute migraines that are poorly addressed with currently-available treatments.”
Read the Impel Neuropharma press release.
