Investigating INP104 for Migraine Treatment: Carrie Dougherty, MD, FAHS

The program director of the Medstar Georgetown University Hospital Headache Medicine Fellowship program discussed further research to be conducted with the nasal delivery of DHE.

“I think there's always a treatment need for a larger patient population within migraine. We recognize migraine affects a broad range of patients. Oftentimes, acute medications are initially evaluated in the most common patient population, which is adults with episodic migraine. But I would like to see more information about this medication in adolescence.”

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

One postInvestigators found that 30 patients reported 39 nausea treatment-emergent adverse events (TEAEs; 0.6% of doses) over 52 weeks and 6332 doses of INP104. Mild nasal congestion was not uncommon (n = 59; 16.7%), but no concerning nasal or cardiovascular TEAEs were reported.1-3

In terms of exploratory efficacy, investigators found that 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 further research she would like to see conducted INP104. She also discussed the history of DHE use.

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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.