Exploratory efficacy of INP104 in migraine patients by prior treatment

Presented at the AHS Annual Scientific Meeting, June 9–12, 2022

Authors: Bilchik, T.R.; Vann, R.; Murphy, M.; Ray, S.; Shrewsbury, S.B.; Aurora, S.K.

One sentence summary: INP104 was associated with improvements in self-reported exploratory efficacy regardless of prior acute treatment, including triptans.

Background: To report the exploratory efficacy of INP104, a drug-device combination product that delivers dihydroergotamine mesylate to the upper nasal space using Precision Olfactory Delivery (POD®) technology, over 24 weeks of treatment based on acute medications used prior to INP104 treatment.

Methods: STOP 301 was a pivotal, Phase 3, open-label study that assessed the safety, tolerability, and exploratory efficacy of INP104. Patients were on their best usual care during a 28-day screening period

(i.e. baseline). Eligible patients continued into a 24-week treatment period and were provided with INP104 to nasally self-administer (1.45 mg) with self-recognized migraine attacks. Daily eDiaries were completed to capture headache and migraine details. This post hoc analysis assessed the exploratory efficacy endpoints of self-reported pain and most bothersome symptom (MBS) freedom 2 hours post-INP104 administration based on acute therapies used prior to study initiation.

Results: A total of 354 patients self-administered at least 1 dose of INP104 over 24 weeks and were included in this analysis. The most commonly used acute therapies prior to INP104 treatment initiation were acetaminophen (43.8%), nonsteroidal anti-inflammatory drugs (NSAIDs; 37.6%), and triptans (28.2%). During Weeks 1–12, migraine attacks self-reported as pain-and MBS-free at 2 hours post-INP104 were 37% and 54% (n = 1152) in acetaminophen users, 36% and 53% (n = 1048) in NSAID users, and 39% and 55% (n = 732) in triptan users. During Weeks 13–24, corresponding pain-and MBS-free rates at 2 hours post-INP104 were 37% and 50% (n = 843) in acetaminophen users, 34% and 53% (n = 691) in NSAID users, and 42% and 59% (n = 449) in triptan users.

Conclusion: Results suggest that INP104 may be an effective acute treatment option for migraine patients regardless of their prior acute treatment, which includes triptans.