Abstract Details

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

Topic Headache

Presentation(s) P15 - Poster Session 15 (5:30 PM-6:30 PM)

Poster/Presentation
Number 15-005

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.

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

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.

Authors/Disclosures
Cynthia E. Armand, MD (Montefiore Medical Headache Center) PRESENTER	Dr. Armand has received personal compensation in the range of $0-$499 for serving as a Consultant for Abbvie. Dr. Armand has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TEVA. Dr. Armand has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Spire Learning. Dr. Armand has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for JAMA Neurology.
Dawn C. Buse, PhD (Dawn C. Buse, PhD)	Dr. Buse has received personal compensation for serving as an employee of Vector Psychometric Group. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie-Allergan. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amgen. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lilly. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Collegium. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lilly. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie-Allergan. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. Buse has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Current Pain and Headache Reports. The institution of Dr. Buse has received research support from Amgen. The institution of Dr. Buse has received research support from FDA. The institution of Dr. Buse has received research support from National Headache Foundation.
Robert Vann, PhD (C2N Diagnostics)	Dr. Vann has received personal compensation for serving as an employee of Impel Neuropharma. Dr. Vann has received personal compensation for serving as an employee of Biogen.
Sutapa Ray, PhD (Impel NeuroPharma)	Dr. Ray has received personal compensation for serving as an employee of Impel Pharmaceuticals. Dr. Ray has stock in Impel Pharmaceuticals.
Stephen B. Shrewsbury, MD (Impel Pharmaceuticals)	Dr. Shrewsbury has received personal compensation for serving as an employee of Impel NeuroPharma. Dr. Shrewsbury has received stock or an ownership interest from Impel NeuroPharma.
Sheena K. Aurora, MD (Department of Neurology and Neurological Sciences)	Dr. Aurora has received personal compensation for serving as an employee of Impel Neuropharma. Dr. Aurora has stock in Impel Neurpharma.