“The take home message is that INP104 is delivering DHE to the upper nasal space and it’s reflecting similar serum plasma levels at 20 minutes as the IV formulation but is also shown to be very tolerable.”
Data from the phase 3, open-label STOP 301 study (NCT03557333) suggest that the novel nasal delivery system of dihydroergotamine mesylate (DHE), INP104, 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 were presented in several posters at the 2021 Virtual American Headache Society (AHS) 63rd Annual Scientific Meeting, June 3-6.
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
Second outcomes of the study included exploratory efficacy. Mean pain- and most bothersome symptom (MBS)-free 2-hours post-INP104 migraine attacks (MAs) ranged from 35.1% to 38.7% and 49.2% to 57.9% compared to 30.6% and 47.9% at baseline, respectively. 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 potential of INP104 to improve migraine patient care. She also discussed some challenges in treating migraine.
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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.