Exploratory Efficacy of INP104 in Migraine Patients by Prior Treatment

Presented at the PAINWEEK Conference, September 6-9, 2022

Authors: Tanya R. Bilchik, MD, FAHS; Robert Vann, PhD; Brett Downing, PhD; Sutapa Ray, PhD; Stephen B. Shrewsbury, MB ChB; Sheena K. Aurora, MD

Introduction: Data suggests that patients are not satisfied with their current acute therapies for migraine. INP104 is a drug-device combination product for the acute treatment of migraine that targets delivery of dihydroergotamine mesylate to the upper nasal space using Precision Olfactory Delivery (POD®) technology. Previously presented data showed that INP104 was well tolerated and associated with improvements in several exploratory efficacy outcomes.

Objective: To report data from a post hoc analysis of the exploratory efficacy of INP104 treatment over 24 weeks based on acute medications used prior to INP104 treatment.

Design/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. 

Results: A total of 354 patients self-administered ≥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 most bothersome symptom (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. 

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