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. 

2022 AAN Annual Meeting

Impel presented four scientific abstracts as part of the 2022 American Academy of Neurology Annual Meeting, including data from our pivotal Phase 3 STOP-301 trial of Trudhesa® for the acute treatment of migraine.

2022 HCOP Winter Conference

Impel attended the 2022 Headache Cooperative of the Pacific’s 14th Annual Winter Conference, held January 28-29 to support communication among headache providers and researchers. This two-day, educational and informative event provides the necessary tools and best practices to better diagnose and treat headache patients.