Abstract Details

Title Consistency of Migraine Pain Relief after Repeated Administration of MAP0004

Topic Headache

Presentation(s) P01 - (-)

Poster/Presentation
Number 086

Objective

Background Oral administration of medication is common for the acute treatment of migraine. Gastric stasis is associated with migraine, and can significantly alter the rate of intestinal absorption of an oral medication, leading to inconsistent response. MAP0004, an investigational dihydroergotamine (DHE) product candidate, delivers DHE systemically via the lungs, bypassing the gastrointestinal tract. DHE Tmax measurements between 9-17 min were consistently recorded in a MAP0004 clinical trial. However, consistent Tmax values do not necessarily correlate with a consistent clinical response.

Design/Methods This post-hoc analysis included subjects enrolled in the MAP0004 cohort of an open-label safety study who experienced at least 25 qualifying migraines (QMs). To assess consistency of MAP0004 efficacy; pain relief, pain free, sustained pain relief, and sustained pain free endpoints were compared between the 1st, 5th, 15th, and 25th QM.

Results A total of 153 subjects were analyzed. Pain relief at 2 hr for the 1st QM was reported by 51.0% of subjects. Compared to the 1st QM, there was no statistically significant difference in the percentage of subjects reporting pain relief at 2 hr for each subsequent migraine. There was no statistically significant difference when comparing across the four migraines evaluated. Similarly, analysis of pain free at 2 hr (1st QM=20.9%), sustained pain relief 2-24 hr (1st QM=36.6%), and sustained pain free 2-24 hr (1st QM=15.0%) were not statistically different from the 1st QM or comparing across the 1st, 5th, 15th and 25th QMs.

Conclusions In this post-hoc analysis, MAP0004 provided consistent migraine pain relief for the 1st, 5th, 15th or the 25th QM assessed over approximately one year.

Authors/Disclosures
Shashidhar Kori, MD PRESENTER	Dr. Kori has received personal compensation for serving as an employee of Novilla Pharma. Dr. Kori has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Satsuma Pharma. Dr. Kori has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Tonix Pharma. Dr. Kori has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Exalys Pharma. Dr. Kori has received personal compensation in the range of $0-$499 for serving as a Consultant for NewBio Pharma. Dr. Kori has received personal compensation in the range of $0-$499 for serving as a Consultant for Afsci Pharma. Dr. Kori has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Trigemina Inc. Dr. Kori has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Novilla Pharma. Dr. Kori has received stock or an ownership interest from Novilla Pharma. Dr. Kori has received stock or an ownership interest from NewBio Pharma. Dr. Kori has received stock or an ownership interest from Tonix Pharma. Dr. Kori has received intellectual property interests from a discovery or technology relating to health care. Dr. Kori has received intellectual property interests from a discovery or technology relating to health care. Dr. Kori has received personal compensation in the range of $0-$499 for serving as a Reviewer of grant applications with Department of Defense.
Biao Lu	No disclosure on file
Emilee C. Connors	No disclosure on file
	No disclosure on file
	No disclosure on file
Donald Kellerman (Zosano)	No disclosure on file

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