Recurrence Rates for INP104 for the Acute Treatment of Migraine: Results from the Phase 3 STOP 301 Open-Label Study

Poster presented at the 15th Annual HCOP Winter Conference; Ojai, CA; January 28-29, 2022

Authors: Stewart J. Tepper, MD, Jessica Ailani, MD, TinaMarie Lieu, PhD, Sheena K. Aurora, MD, Stephen B. Shrewsbury, MB ChB

Introduction: Recurrence of migraine headache is common with acute treatment and is associated with potential development of medication overuse in some patients. Intravenous dihydroergotamine mesylate (DHE) has been associated with a low risk of migraine recurrence. We evaluated self-reported recurrence and sustained pain freedom rates over 24 and 52 weeks withnasal DHE delivered with Precision Olfactory Delivery (POD^®) technology, INP104.

Objective: To evaluate self-reported sustained pain freedom rates and headache recurrence rates for INP104 in STOP 301. (Clinicaltrials.gov identifier NCT03557333).

Methods: The STOP 301 study was a pivotal, interventional, open-label, Phase 3 study assessing the safety, tolerability, and exploratory efficacy of INP104 over 24 or 52 weeks. In total, 354 patients comprised the full safety set (FSS; i.e., all patients who enrolled and received ≥ 1 dose of INP104 1.45 mg) and were treated in the 24-week period. Recurrence was defined as the onset of a new headache prior to 24 or 48 hours post-dose in patients who were pain-free at 2 hours post-dose.

Results: Sustained pain freedom (i.e., no recurrence at 24 hours and no other medication taken between the time of study drug administration and 24 or 48 hours later) was self-reported in 35.2% (117/332) and 32.5% (108/332) of patients at 24 and 48 hours, respectively, for the first treated migraine attack (FSS) while recurrence was self-reported in 7.1% (9/126) and 14.3% (18/126) of patients who treated their first migraine attack with INP104, respectively. Overall, 37% of 4,295 attacks achieved pain freedom by 2 hours, with sustained pain freedom rates of 35% (1491) at 24hrs and 32% (1360) at 48hrs over 24 weeks.

Conclusion: Data from this Phase 3 study demonstrates that the first INP104-treated migraine attack is associated with very low rates of recurrence through 24 and 48 hours post-dose.