Improvements in Disability, Migraine Frequency, and the Interictal Period with INP104: Results from the Phase 3 STOP 301 Study

Presented at the AAN Annual Meeting, April 2-7, 2022 

Authors: Cynthia E. Armand, Dawn C. Buse, Robert Vann, Sutapa Ray, Stephen B. Shrewsbury, Sheena K. Aurora

Objective: To report data from a post hoc analysis on headache-related disability and exploratory outcome measures relevant to interictal burden following INP104 treatment.

Background: There is a need for effective acute therapies to rapidly resolve migraine symptoms with sustained benefit. Reduction of monthly migraine attacks (MAs) and associated disability are important goals. INP104 is a drug-device combination product of dihydroergotamine mesylate and Precision Olfactory Delivery technology. 

Design/Methods: STOP 301 was a Phase 3, open-label study that assessed the safety, tolerability, and exploratory efficacy of INP104. Patients were on their best usual care during a 28-day screening period (i.e. baseline). Eligible patients continued into a 24-week treatment period, with a subset continuing into a 28-week extension. Patients were provided with INP104 (1.45 mg) to nasally self-administer with self-recognized MAs. Exploratory outcome measures included results from the Migraine Disability Assessment (MIDAS) questionnaire, time between MAs, and frequency of monthly MAs.

Results: A total of 354 patients self-administered ≥1 INP104 dose over 24 weeks (24-week full safety set [FSS]) and 73 continued into the 28-week extension (52-week FSS). At baseline, the mean MIDAS total score for the 24-week FSS was 25.1. The mean change from baseline was -5.5 and -7.4 at Weeks 12 and 24, respectively. At baseline, the mean MIDAS total score for the 52-week FSS was 24.6. At Weeks 12, 24, 36, and 52, the mean change from baseline was -5.8, -5.1, -7.8, and -8.9, respectively. During Weeks 1-24, the median time between MAs was 6 days compared to 4 days at baseline. At baseline, the mean frequency of monthly MAs was 4.7 vs 3.7, 3.0, 2.6, 2.5, 2.4, and 2.4 at Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24, respectively. 

Conclusions: INP104 use was associated with reduction in disability and frequency of monthly MAs, and increase in time between MAs.