Patient Acceptability of a Novel Upper Nasal Delivery System for Dihydroergotamine Mesylate Using the Precision Olfactory Delivery (POD®) Device – Results From the Open-label STOP 301 Trial
posted in Presentations by Jennifer Price
Presented at the 2020 Diamond Headache Clinic Research & Educational Foundation (DHCREF) Virtual Meeting: The New Paradigm of Treatment for the Headache Patient
Authors: Stephen B. Shrewsbury, Sheena K. Aurora, John Hoekman, Maria Jeleva
To report the safety, tolerability, exploratory efficacy, and patient acceptability of POD DHE mesylate (INP104) over 24 weeks from the pivotal, Phase 3 STOP 301 clinical trial.
This was a pivotal Phase 3, interventional, open-label, single-group assignment study, assessing the safety, tolerability, patient acceptability, and exploratory efficacy of INP104 (NCT 03557333) over long-term use. The study was comprised of a 4-week screening period, a 24-week treatment period for all patients, a treatment extension to 52 weeks for a subset of the patients, and a 2-week post-treatment follow-up period.
360 patients were enrolled in the 24-week treatment period; 354 patients received at least one dose of INP104 (the full safety set) and if they took 2 or more treatments per 4-weeks, these patients were referred to as the primary safety set. 74.6% persisted with treatment and completed the 24-week study. Treatment-emergent adverse events, mostly mild, are reported in Figure 3. The exploratory endpoints of pain-and most bothersome symptom freedom at 2 hours showed improvement compared to best usual care (Figure 4). Pain relief began as early as 15 minutes and more than two thirds of patients achieved pain relief at 2 hours (Figure 5). The well-known efficacy of DHE is particularly emphasized in sustained pain freedom in figure 6 with less than 2% reporting relapse over 24 hours. Patients were also provided with a questionnaire about the acceptability of INP104 (Figure 7). The majority of patients felt the study drug was easy to use and carry.
There were no new safety signals following delivery to the upper nasal space, and with a patient acceptability questionnaire, it was determined that the majority of patients found INP104, the combination product of POD and DHE mesylate, easy to use and preferred it over their current therapy. Exploratory efficacy data suggests that INP104 resulted in pain freedom in 33.1% of patients, most bothersome symptom freedom in 49.1% of patients, and pain relief in 66.3% of patients at 2 hours. Additionally, sustained pain freedom through 24 hours was also reported in the majority of patients with 98.4% of patients remaining relapse-free of their migraine after using INP104 for 24 weeks. These results suggest that delivery to the upper nasal space may provide an effective, consistent, and well-tolerated alternative to acute oral and injectable treatments for migraine, while providing the reliable efficacy, speed, and potency of the long-established DHE molecule.
Shrewsbury SB, Aurora SK, Hoekman J, Jeleva M, Patient Acceptability of a Novel Upper Nasal Delivery System for Dihydroergotamine Mesylate Using the Precision Olfactory Delivery (POD®) Device – Results From the Open-label STOP 301 Trial, 2020 Diamond Headache Clinic Research & Educational Foundation (DHCREF) Virtual Meeting.