STOP 301 Study of INP104 for Migraine: Carrie Dougherty, MD, FAHS

"IV DHE has been around since the 1950s for acute treatment of migraine, and it really hasn't changed over time. The limited utility of an intravenous medication for acute migraine is most apparent in the way that you administer the medication. It's just not appropriate for patients with migraine."

Recent data from the phase 3 open-label STOP 301 study (NCT03557333) suggest that INP104, a novel nasal delivery system of dihydroergotamine mesylate (DHE), is associated with improvements in several migraine measures with low recurrence rates and consistent efficacy throughout a 24-week stretch, as well as an acceptable safety profile. Findings from the study were presented at the 2021 Virtual American Headache Society (AHS) 63rd Annual Scientific Meeting, June 3-6, in several posters. 

In an analysis of the full safety set, investigators of the study found that over 52 weeks and 6332 doses of INP104, 30 patients reported 39 nausea treatment-emergent adverse events (TEAEs; 0.6% of doses). While mild nasal congestion was not uncommon (n = 59; 16.7%), no concerning nasal or cardiovascular TEAEs were reported.^1-3

The investigators also looked at exploratory efficacy and found that the mean number of migraine attacks (MAs) self-reported as pain- and most bothersome symptom (MBS)-free 2-hours post-INP104 ranged from 35.1% to 38.7% and 49.2% to 57.9% compared to 30.6% and 47.9% at baseline, respectively. In terms of consistency, over 24 weeks, 25%, 57%, and 59.9% of patients were 100%, 75% or greater, and 67% or greater responders, respectively.^4-6

NeurologyLive spoke with Carrie Dougherty, MD, FAHS, associate professor of neurology, and program director, Headache Medicine Fellowship program, Medstar Georgetown University Hospital, to learn more about the STOP 301 study data. She also detailed how INP104 compares to traditional intravenous DHE for migraine.

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REFERENCES

1. Randle L, Aurora SK, Hocevar-Trnka J, Shrewsbury SB. Reduced nausea when dihydroergotamine mesylate is delivered by INP104. Presented at 2021 AHS Annual Scientific Meeting; June 3-6. Abstract P166.
2. Craig K, Jeleva M, Hocevar-Trnka J, Aurora SK, Shrewsbury SB. Cardiovascular safety results of INP104 (POD-DHE) from the STOP 301 phase 3 study. Presented at 2021 AHS Annual Scientific Meeting; June 3-6. Abstract P181.
3. Davis G, Fatakia A, Pransky S, et al. Nasal safety of chronic intermittent use of INP104: Results from the phase 3 open-label STOP 301 study. Presented at 2021 AHS Annual Scientific Meeting; June 3-6. Abstract P182.
4. Smith TR, Aurora S, Hocevar-Trnka J, Shrewsberry S. Acute treatment of migraine with INP104: exploratory efficacy from the phase 3 STOP 301 study. Presented at 2021 AHS Annual Scientific Meeting; June 3-6. Abstract P180
5. Lipton RB, Nye BL, Hirman J, Shrewsbury SB, Aurora SK. Treatment consistency across multiple migraine attacks: results from the phase 3 open-label STOP 301 study. Presented at 2021 AHS Annual Scientific Meeting; June 3-6. Abstract ­P183
6. Tepper SJ, Ailani J, Shrewsbury SB, Aurora SK. Recurrence rates for INP104 for the acute treatment of migraine: results from the phase 33 STOP 301 study. Presented at 2021 AHS Annual Scientific Meeting; June 3-6. Abstract 179.