Impel NeuroPharma announced that it has submitted an NDA for its INP104 dihydroergotamine mesylate intranasal (DHE) for the treatment of migraine headaches with or without aura, which is delivered via the company’s Precision Olfactory Delivery (POD) technology. Impel reported positive results from the STOP 301 Phase 3 trial of INP104 in June 2020.
Impel Neuropharma Chairman and CEO Adrian Adams said, “The submission of INP104 represents our first NDA and marks a major milestone for Impel as we rapidly advance our pipeline of differentiated, potentially transformative therapies for people living with CNS disorders. Based upon the previously reported positive results of the STOP 301 study, we believe that INP104 has the potential to provide an important new option for people who need a fast, effective, and consistently reliable acute treatment of migraine headaches.”
The company’s pipeline also includes intranasal formulations of olanzapine for the treatment of acute agitation and levodopa for the treatment of OFF episodes in Parkinson’s disease, both delivered via the company’s POD device.
Read the Impel Neuropharma press release.
