Abstract Details

Title Efficacy of MAP0004 in Treating Severe Migraine Pain

Topic Headache

Presentation(s) P01 - (-)

Poster/Presentation
Number 082

Objective

Background The treatment needs of migraine patients are often unmet by available therapies. Severe migraines, in particular, have been shown to be more difficult to treat. MAP0004, an investigational product candidate which delivers dihydroergotamine (DHE) systemically via oral inhalation, was superior to placebo for the acute treatment of migraine in a Phase 3 trial.

Design/Methods This post-hoc analysis examined migraine pain relief, pain free, sustained pain relief, sustained pain free and recurrence endpoints as reported by subjects who had severe migraine pain at the time of treatment in a randomized, placebo-controlled, MAP0004 Phase 3 clinical trial.

Results Severe migraine pain was reported by 366 of the 794 subjects in the trial. Subjects with severe migraine pain who received MAP0004 experienced statistically significant pain relief compared to placebo (p<0.05) at 10 minutes and at all subsequent time points studied. Significantly more subjects with severe migraine pain who received MAP0004 were pain free (p<0.05) compared to placebo at 60 min and at all subsequent time points studied. Sustained pain relief and sustained pain free, both between 2-24 and 2-48 hr, were statistically significantly higher for MAP0004 recipients compared to placebo. Headache recurrence over 24 hr occurred in 6.2% of subjects with severe migraine pain receiving MAP0004 as compared with 18% for placebo.

Conclusions This analysis indicates that MAP0004 was effective in the acute treatment of severe migraine pain in the Phase 3 clinical trial.

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.
Leon A. Weinstock, MD (University Neurology, INC)	Dr. Weinstock has nothing to disclose.
Emilee C. Connors	No disclosure on file
	No disclosure on file
Biao Lu	No disclosure on file
	No disclosure on file
Carla Tortorella (Universitaria Consorziale Policlinico)	No disclosure on file

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