The United States Food and Drug Administration (FDA) has accepted for review United States-based Impel NeuroPharma's 5O5(b)(2) New Drug Application (NDA) for INP104 intended for the acute treatment of migraine headaches with or without aura in adults, it was reported on Wednesday.

The product is dihydroergotamine mesylate that is supplied into the vascular-rich upper nasal space using the company's proprietary Precision Olfactory Delivery technology. If approved, it will be marketed under the trade name, TRUDHESA in the United States.

The NDA submission is supported by safety results from the pivotal Phase three STOP 301 study, in which over 5,650 migraine attacks were treated during 24 or 52 weeks. The study met its primary objectives, with no new safety signals or concerning trends in nasal safety findings observed for the product following delivery of dihydroergotamine mesylate to the upper nasal space.

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of 6 September 2021, which reflects a standard 10-month review period and is consistent with the review timeline for a 505(b)(2) NDA submission.