Clinical Takeaways From INP104 Data in Migraine: Sheena K. Aurora, MD

“Of course, DHE is not for everyone—we have contraindications in patients with cardiovascular disease and cerebrovascular disease, and those patients were excluded from STOP 301—but we also have a cardiovascular evaluation that we presented at AHS. The good news is that there are no new findings. Obviously, this has to be viewed [in the instances] where clinicians would use DHE.”

At the 2021 Virtual American Headache Society (AHS) 63rd Scientific Annual Meeting, June 3-6, a number of presentations were given centering around an investigational nasal formulation of a long-time migraine treatment, dihydroergotamine (DHE). This agent, developed by Impel Neuropharma, is referred to as INP104. The agent is delivered via a drug-device in a dose of 1.45 mg administered to the upper nasal space using the company’s Precision Olfactory Delivery (POD) technology.

Some of these data included the findings of the recent STOP 301 trial (NCT03557333) of INP104, which assessed the agent over a long-term period in patients with migraine. The data showed an acceptable safety profile, though safety should be monitored with intermittent use of the medication.

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

To find out more about what the clinical community should take away from these data, NeurologyLive spoke with Sheena Aurora, MD, Vice President, Medical Affairs – Migraine, Impel Neuropharma, who presented some information about the role of DHE in treating migraine on a broad-receptor basis. She shared her insight into the data and offered her perspective on what the clinician community should note from these datsets.

For more coverage of AHS 2021, click here.

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.