Recurrence Rates for INP104 for the Acute Treatment of Migraine: Results from the Phase 3 STOP 301 Open-Label Study
posted in Presentations by Brooke Eger
Poster presented at the 2021 American Headache Society (AHS) Virtual Annual Scientific Meeting.
Authors: Stewart J. Tepper, MD, Jessica Ailani, MD, Sheena K. Aurora, MD, Stephen B. Shrewsbury, MB ChB
Recurrence of migraine headache is common with acute treatment (particularly with the triptan class) 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 with nasal DHE delivered with Precision Olfactory Delivery (POD®) technology, INP104.
To evaluate self-reported sustained pain freedom rates and headache recurrence rates for INP104 by conducting a post hoc analysis of exploratory efficacy data from the STOP 301 study. (Clinicaltrials.gov identifier NCT03557333).
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 were enrolled and received at least 1 dose of INP104) and were treated with INP104 (1.45 mg) 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.
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 hours and 48 hours, respectively, for the first treated migraine attack (FSS). Recurrence at 24 hours and 48 hours post-dose 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 similar sustained pain freedom rates for the 24-week period, 35% (1491) at 24hrs and 32% (1360) at 48hrs.
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.
Tepper SJ, Ailani J, Aurora SK, MD, Shrewsbury SB, Recurrence Rates for INP104 for the Acute Treatment of Migraine: Results from the Phase 3 STOP 301 Open-Label Study, 2021 American Headache Society (AHS) Virtual Annual Scientific Meeting.