Nasal Delivery of DHE for Migraine: Carrie Dougherty, MD, FAHS

“The limitation of IV DHE is, oftentimes, the IV medication gives patients a lot of nausea as a [adverse] effect. So, in my clinic, whenever we use IV DHE, we pre-treat with anti-nausea medication to decrease that [adverse] effect profile and nausea medication often has its own constellation of [adverse] effects, so then you have 2 [adverse] effect profiles that you're dealing with.”

Recent data 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. These findings from the phase 3, open-label STOP 301 study (NCT03557333) were presented at the 2021 Virtual American Headache Society (AHS) 63rd Annual Scientific Meeting, June 3-6, in several posters.

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). Mild nasal congestion was not uncommon (n = 59; 16.7%), but no concerning nasal or cardiovascular TEAEs were reported.^1-3

Looking at exploratory efficacy, investigators also 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 novel Precision Olfactory Device (POD®) that INP104 employs. She discussed the advantages of the treatment compared to intravenous DHE and other currently approved DHE nasal spray formulations.

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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.