According to Impel NeuroPharma, the FDA has accepted the company’s 5O5(b)(2) NDA for its INP104 intranasal dihydroergotamine mesylate (DHE) for the treatment of migraine headaches and has set a PDUFA goal date of September 6, 2021. The agency has also conditionally accepted the trade name “Trudhesa.” Impel submitted the NDA for INP104, its first US regulatory submission, in November 2020.
Impel Neuropharma Chairman and CEO Adrian Adams commented, “The FDA’s acceptance of our submission package for Trudhesa marks another important step in our journey to bring an important new treatment option to patients who, despite recent treatment advances, are still in need of a fast, effective, and consistently reliable relief from their migraine. Our proprietary POD technology has the potential to unlock the therapeutic viability of a previously untapped treatment pathway, the vascular-rich upper nasal space. We are hopeful that patients with migraine who are still in search of an acute treatment that is both non-oral and on-demand will have access to such an option later this year and look forward to working closely with the FDA as it completes its review of our application.”
Read the Impel Neuropharma press release.
