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.

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.

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 .

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.

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.