Impel NeuroPharma NDA for Migraine Drug

FDA has accepted for review an Impel NeuroPharma 5O5(b)(2) NDA for INP104 (dihydroergotamine mesylate) for the acute treatment of migraine headaches with or without aura in adults. The company says INP104 is intended to be delivered directly into the vascular-rich upper nasal space using Impel’s proprietary Precision Olfactory Delivery technology. If approved, it will be marketed under the trade name Trudhesa. The agency has set a 9/6 user fee review action target date.

The submission is supported by safety data  from the pivotal Phase 3 STOP 301 study, in which more than 5,650 migraine attacks were treated over 24 or 52 weeks. The study met its primary objectives, with no new safety signals or concerning trends in nasal safety findings observed for Trudhesa following delivery to the upper nasal space, according to Impel NeuroPharma. “No drug-related serious adverse events were observed over the entire 52-week study,” it says.