Safety of Concomitant Triptan and INP104 Use Reported from Migraine Study Subset

In data presented at the American Academy of Neurology (AAN) 2023 Annual Meeting, a small subset of participants from study STOP 301 reported taking a triptan within 24 hours of self-administering the study medication INP104, a combination of dihydroergotamine mesylate (DHE) and Precision Olfactory Delivery (nasal delivery). Both DHE and triptans act on 5-HT_1B/1D receptor subtypes which contribute to vasoconstrictive effects, therefore administering a triptan within 24 hours of DHE is contraindicated, and participants were advised against taking at triptan for the duration of the study.

Of the 354 participants enrolled in the study, 10 participants reported taking a triptan >1 time within 24 hours of administering study medication. Of the 10 participants, 7 reported 15 treatment-emergent adverse events (TEAEs). Nasal congestion occurred in one instance on the day of INP104 administration and was resolved before the reported triptan use 6 hours later. In a 2^nd instance, epistaxis occurred 2 days after concurrent use of the study medication and a triptan, for a total of 2 TEAEs. The TEAEs reported by the remaining 5 participants were deemed to be unrelated to concomitant use of INP104 and triptan. There were no reported TEAEs related to blood pressure, pulse, or electrocardiogram parameters, and any variance was within normal clinical limits.