Abstract Details

Title Analysis of MAP0004 Subjects with Menstrually Related Migraine vs. Non-Menstrually Related Migraine

Topic Headache

Presentation(s) P01 - (-)

Poster/Presentation
Number 072

Objective

Background Menstrually related migraine is defined by The International Classification of Headache Disorders, 2nd edition (ICHD-2) as a migraine occurring from days -2 to +3 of menstruation in at least 2 out of 3 menstrual cycles and additionally at other times of the menstrual cycle. Menstrually related migraine is generally longer lasting, more severe, and more difficult to treat compared to non-MRM. MAP0004 is an investigational product candidate which delivers dihydroergotamine (DHE) through the lungs via a breath-synchronized metered dose inhaler (TEMPO®).

Design/Methods This post-hoc analysis compared the efficacy of MAP0004 in treating MRM and non-MRM using the following clinical endpoints: pain relief, pain free, sustained pain relief, and sustained pain free.

Results The efficacy of MAP0004, as measured by pain relief at 2 hr, pain free at 2 hr, sustained pain relief 2-24 and 2-48 hr, and sustained pain free 2-24 and 2-48 hrs, was not significantly different between subjects with MRM and non-MRM. There were no significant differences in the frequency of adverse events for MRM vs. non-MRM subjects treated with MAP0004, and no drug-related serious adverse events were reported.

Conclusions In this post-hoc analysis of a Phase 3 study, MAP0004 was similarly effective and tolerated in treating both MRM and non-MRM.

Authors/Disclosures
Sheena K. Aurora, MD (Department of Neurology and Neurological Sciences) PRESENTER	Dr. Aurora has received personal compensation for serving as an employee of Alzheimer's Association.
Biao Lu	No disclosure on file
Emilee C. Connors	No disclosure on file
	No disclosure on file
Donald Kellerman (Zosano)	No disclosure on file
Shashidhar Kori, MD	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.
	No disclosure on file

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