Healthcare Utilization in Patients With Acute Migraine: Pre- and Post-Treatment With INP104 in a Phase 3 Study

Presented at the 2021 Virtual AAN Annual Meeting. April 17-21, 2021

Authors:

Carrie Dougherty, Sheena Aurora, Stephanie Bariahtaris, Stephen Shrewsbury, Marissa Baker-Wagner, Naomi Sacks, Sharon Kautz, Phil Cyr, Benjamin Friedman

Objective:

To assess certain healthcare resource utilization (HCRU) impacts of treating acute migraine with INP104 (dihydroergotamine (DHE) mesylate administered to the upper nasal space by a drug-device combination product) compared to the prior period on best usual care.

Background:

Migraine is associated with high rates of emergency department (ER) and urgent care (UC) visits. One of the goals of acute migraine treatment is to optimize self-care and reduce HCRU. INP104 uses the novel, self-administered Precision Olfactory Delivery (POD®) device for efficient drug administration, rapid absorption and high bioavailability.

Design/Methods:

An analysis of HCRU data was conducted from the phase 3, multicenter, open-label STOP301 study of INP104 in patients with a documented diagnosis of migraine and at least two attacks/month during the previous six months. HCRU was an exploratory endpoint. Data were patient self-reported for the 12-month baseline period of best usual care at the screening visit and prospectively collected in the patient’s eDiary for the 24-week period on treatment. ER visits, UC visits and hospitalizations were analyzed for the 354 patients who received at least one dose of INP104. Change from baseline for the exposure-adjusted event rate (EAER), defined as the expected number of specific events per 100 person-years of exposure, was calculated. Paired t-tests assessed the significance of these changes.

Results:

When compared to the previous 12 months on best usual care, there was a 73% reduction in the event rate of ER visits (9.9 to 2.6; p<0.05), and a 100% reduction in UC visits (7.1 to 0; p<0.01) and hospitalizations (0.6 to 0; p=0.16) while on INP104. This is the first phase 3 study in acute migraine, to our knowledge, to collect and report HCRU data.

Conclusions:

Patients treating acute migraine with INP104 reported significant reductions in HCRU. Treatment with INP104 may benefit patients by reducing or eliminating ER and UC visits.

Citation:
Healthcare utilization in patients with acute migraine: pre- and post-treatment with INP104 in a phase 3 study (2395)
Carrie Dougherty, Sheena Aurora, Stephanie Bariahtaris, Stephen Shrewsbury, Marissa Baker-Wagner, Naomi Sacks, Sharon Kautz, Phil Cyr, Benjamin Friedman
Neurology Apr 2021, 96 (15 Supplement) 2395;