27 June 2018 - - Seattle, Washington-based biotechnology company Impel NeuroPharma has received notification from the US FDA of clearance to proceed with the clinical investigation of INP104, a dihydroergotamine (DHE) product dosed via Impel's proprietary precision olfactory delivery (POD) intranasal delivery device for the treatment of acute migraine, the company said.
DHE is an established and highly-effective option for acute migraine treatment. INP104 is an investigational new drug-device combination product being studied for acute migraine headache. It is comprised of an intranasal formulation of DHE and Impel's POD device.
The POD is a simple-to-use device designed to deliver consistent and predictable doses of drug. INP104 delivers DHE to the richly vascularized upper nasal cavity, offering rapid bioavailability without injection.
Impel NeuroPharma, a privately held company devoted to creating therapies for central nervous system diseases, has multiple therapies in clinical development to treat conditions such as migraine, Parkinson's, and Alzheimer's.
The company's products are based on a novel nasal drug delivery platform called POD technology which administers liquid or dry medication to the deep nasal cavity, enabling entirely new categories of drugs, including biologics, to be administered using a cost-effective, disposable, non-invasive method.